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HPN

Issue 33

HOSPITAL PROFESSIONAL NEWS IRELAND

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TOP 100 PROFESSIONAL ISSUE

Ireland’s Dedicated Hospital Professional Publication

The HPN Top 100 Professional 2016

IN THIS ISSUE: NEWS: Pharmacy Memorandum of Understanding Page 5 PROFILE: Leadership in Healthcare says Prof Freddie Wood Page 18 AWARDS: In-depth Case Studies Page 24 CPD: Treating Hep C in the PWID Population Page 53 FEATURE: Prostate Cancer Page 90 CONFERENCE: Aseptic Services Group Page 100

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Top 100 Professional Issue Issue 33

Contents

Foreword

Simon Harris discusses medicines shortages with EU Health Ministers P4

Editor

Kelly Jo Eastwood “The New Year stands before us, like a chapter in a book, waiting to be written. We can help write that story by setting goals.”

IPHA Annual Conference P8 4

The need for Cancer Trials to be Mainstreamed P22 Working together is key - Hospital Pharmacy Team of the Year P36

Joan Peppard, President of the European Association of Hospital Pharmacists looks to the future for the sector on page 12, whilst on page 18 Professor Freddie Wood, President of the Irish Medical Council tells us leadership is a fundamental aspect of patient care.

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HPN Professional Top 100 P60

Mr Oliver O’Connor, CEO of IPHA tells on page 20 highlights, amongst other issues, the need to get to grips with falsified medicines, stating, “It is a mandate we take very seriously as it will provide even higher assurance to patients about their medicines.”

Regulars CPD: Hepatitis C P53 18

Feature: Prostate Cancer P90

Event Gallery: P105 60

Hospital Professional News is Circulated to all independent, multiple and hospital pharmacist, pre reg pharmacists, students pharmacy student’s offi cial bodies, government officials and departments, Pharmacy Managers, Manufactures, Wholesalers. Buyers of pharmacy groups and healthcare outlets. Circulation is free to all pharmacists Subscription rate for Hospital Pharmacy News ¤60 plus vat per year All rights reserved by Hospital Professional News. All material published in Hospital Professional News is copyright and no part of this magazine may be reproduced, stored in a retrieval system of transmitted in any form without written permission. Pharmacy Communication Ireland have taken every care in compiling the magazine to ensure that it is correct at the time of going to press, however the publishers assume no responsibility for any effects from omissions or errors.

PUBLISHER IPN Communications Ireland Ltd Clifton House, Lower Fitzwilliam Street, Dublin 2 (01) 669 0562 MANAGING DIRECTOR Natalie Maginnis n-maginnis@btconnect.com EDITOR Kelly Jo Eastwood kjeastwood@hotmail.com 00447876548989 ACCOUNTS Rachel Wilson cs.ipn@btconnect.com

On page 22 CEO of Cancer Trials Ireland Eibhlin Mulroe says the challenge for the year ahead is to build on the very positive track record of commitment and the expertise of clinicians and researchers around the country in opening and running valuable cancer trials. We also have 26 pages carrying in-depth case study reports of all of this year’s Hospital Professional Award winners, allowing you the chance to read about what makes a winning entry. These profiles are a prime example of collaboration and team work and reflect the ethos of the Awards, which is to showcase learning from example and sharing of ideas and innovations.

Feature: Stroke P94

Clinical Profiles: P107

As we look towards welcoming 2017, this bumper issue of Hospital Professional News carries a plethora of commissioned reports by Ireland’s leading hospital and pharmaceutical representative bodies; each giving us an exclusive overview of their year to date and outlining the challenges and opportunities for the next twelve months.

COMMERCIAL MANAGER Sharon Kennedy

Lastly, we have our annual Hospital Professional Top 100. This feature is a network of the most influential hospital professionals from a number of disciplines, both in a healthcare and pharma industry role, who act as ambassadors and role models for their peers, colleagues and the rising stars of tomorrow. Those who have made our final list have displayed motivating behaviour affecting the development of hospital services within Ireland. Featured in this year’s list are people from a variety of backgrounds. Though the roles our finalists play in are diverse, everyone of them has one thing in common: an unfailing commitment to the development of the hospital healthcare sector.

Sharon@ipnirishpharmacynews.ie

Mobile: 0044 7765 236886 CONTRIBUTORS

We would like to take this opportunity to wish all of our readers a very Merry Christmas, and a prosperous New Year!

Oliver O'Connor, Lorraine Nolan, Professor Freddie Wood, Eibhlin Mulroe, Fionnuala Kennedy, Joan Peppard, Laura Lyons, Richard Corbridge, Matthew Hickman, Daniela De Angelis, Peter Vickerman, Sharon Hutchinson, Natasha Martin

DESIGN DIRECTOR Ian Stoddart Design www.pharmacynewsireland.com www.facebook.com/ HospitalProfessionalNews

HOSPITAL PROFESSIONAL NEWS IRELAND Ireland’s Dedicated Hospital Professional Publication HPN • Professional Top100 - 2016


4 News

EU Health Ministers meet in Bratislava to discuss medicines shortages The Government of Slovakia recently hosted a meeting of European Union (EU) Health Ministers at which the topic of medicines shortages, and the prospects for greater intergovernmental collaboration, received prominent attention. Taking place in Bratislava between 3rd and 4th October 2016, subsequent reports have shined some light on the nature of the discussions. The meeting took place in the context of Slovakia's assumption of the 6 month rotating Presidency of the EU Council of Ministers. Ireland’s Minister for Health Simon Harris was in attendance and also had one to one meetings with Health and Food Safety Commissioner Andriukatis; Swedish Minister for Health and Sport, Gabriel Wikstrom; Dutch Minister for Health, Welfare and Sport, Edith Schippers and UK Minister for Public Health, David Prior. The Minister had discussions on areas of common interest and opportunities for collaboration. In

particular EU Ministers for Health were anxious to discuss and explore ways to ensure greater affordability and better access to medical products.

Health Minister Simon Harris with Vytenis Andriukaitis, European Commissioner for Health and Food Safety

Minister Harris met with EU Commissioner for Health and Food Safety, Vytenis Andriukaitis. During the meeting he thanked him for his full support for the Irish (Public Health) Alcohol Bill and stated that he was very much looking forward to working closely with the Commissioner on an enhanced public health agenda over the coming years. Minister Harris also raised the particular implications for Ireland, of the UK’s decision to leave the EU. In this context Minister Harris referenced the relocation of the European Medicines Agency currently located in London. The Minister said, “Ensuring continuity of and minimising disruption to the work of the Agency when it relocates is essential. A move to Dublin provides a sound, sustainable base for the EMA’s current standards of excellence.”

significantly to the work of the EMA. The Ministers of Health discussed the issue of shortages of medicines for human use, which is at the top of the political agenda in many European countries. Low prices of medicines leading to parallel exports, disruption in production and shortages of active substance are among the reasons for the problem. The Minister emphasised Ireland’s position as a leading location for existing pharmaceutical industry in the EU with nine out of the ten largest pharmaceutical companies in the world operating out of Ireland. Ireland also has a strong track record in the research and development field, as well as a highly regarded national medicines regulator in the Health Products Regulatory Authority (HPRA), which already contributes

Ministers agreed that Member States can succeed in solving this issue through early and operational exchanges of information and regular mapping of the situation. Co-operation between Member States in this area is of high priority. Minister Harris welcomed the proposals for EU member states to work together to address the issue.

Clinical trial transparency problems A new transparency study has confirmed that roughly half of all clinical trials run by pharmaceutical companies, universities and other major research sponsors remain unpublished. TrialsTracker is a tool developed at the University of Oxford that automatically rates transparency on clinical trials by checking if there are results available in clinicaltrials.gov and PubMed. The tool provides a league table of companies and institutions and the percentage of their completed trials that have been published. Results vary with some companies and institutions scoring as high as 65% of trials unpublished, with other companies institutions scoring 100% published. Meanwhile, in a move hailed as a landmark for transparency in medical science, the European Medicines Agency has begun to publish details of the full clinical-trial data that it receives from pharmaceutical companies. On 20 October, the agency published 100 clinical reports about two EMA-approved medicines (carfilzomib, a cancer drug, and lesinurad, a gout treatment) that together run to around 260,000 pages. The disclosures make the EMA the first major regulatory agency to publish the warts-and-all results of clinical investigations that developers of medicines submit when they apply for the agency's approval to market medicines in the European Union.

NCHDs to ballot for industrial action The Council of the Irish Medical Organisation met recently and has unanimously supported Non Consultant Hospital Doctors in their ongoing and longstanding efforts to have their contracts honoured in terms of the unilateral withdrawal of a Living Out Allowance in 2012 and other issues around training. While negotiations on these matters are due to commence Professional Top100 - 2016 • HPN

next week the IMO Council fully support their colleagues in taking industrial action, up to and including strike action, to resolve matters should the negotiations not yield an adequate response from Government. The HSE and Department of Health refused to negotiate on the issues over the past number of years and instead have forced doctors to resort to legal proceedings in the High

Court and now the possibility of industrial action. IMO Council have strongly criticised the Government and in particular the Department of Public Expenditure and Reform for policies that are endangering our health services and patient safety with a health system that has too few consultants, increasing trends of emigration amongst our NCHDs, GP services at crisis

point and inadequate public health planning. The direct consequence to patients of such policies are increasing waiting times, too few hospital beds, cancellation of procedures, persistent overcrowding in our Emergency Departments and inadequate resources to provide care at GP level.


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Doctors Need to Demonstrate Leadership The Medical Council held a Patient Safety & Leadership Conference, ‘Enhancing the Culture of Patient Safety’ at the Radisson Blu Royal Hotel, Golden Lane last month. Astronaut Colonel Eileen Collins who was the first female to pilot and command an American space shuttle is a keynote speaker at the event and spoke on the principles of teamwork, including the key factors for successful leadership along with columnist and author of two acclaimed books on the science of high performance, Matthew Syed. Opening the conference President of the Medical Council Professor Freddie Wood said, “Leadership is an absolutely fundamental facet of good patient care and if there is an issue in the health system, it is the role of doctors, and indeed

all others working within to speak out and advocate on behalf of the patients they treat.” Professor Wood went on to praise doctors for advocating on behalf of their patients however he said sometimes doctors can feel conflicted in certain sporting scenarios saying, “It is understandably very difficult for doctors to be dispassionate if they are the medical advisor for a team or club. “Most of us are familiar with the ongoing debate around the dangers of concussion in sport and in this situation I strongly believe doctors have a professional and moral duty to put their patient first; no matter what their employer, club, school or county must come second, as the welfare of sports people must be a

far higher priority than whether or not a team wins or loses.” Other speakers at the conference included Director of the Clinical Effectiveness and Evaluation Unit at the Royal College of Physicians of London, Dr Kevin Stewart and Council member and external lead advisor for the World Health Organisation’s Patients for Patient Safety Programme, Ms Margaret Murphy.

members of the public is entitled Working with Your Doctor: Useful Information for Patients .

The Medical Council developed a patient booklet following the launch of the 8th Edition of the Medical Council’s Guide to Professional Conduct and Ethics for Registered Medical Practitioners (8th Edition) earlier this year which sets out the standards of practice doctors are expected to follow . The online booklet for patients and

Speaking at the conference, Ms Margaret Murphy, who is also a member of the Medical Council’s Ethics and Professionalism Committee, spoke about the patient booklet saying: “ This online booklet which was recently launched is extremely useful as it informs members of the public on aspects of care which they may not otherwise consider, for example what they can expect from their doctor, what their doctors needs to know and what to do if something goes wrong. If a patient goes into their doctor feeling more knowledgeable and informed, the experience is likely to be better and most importantly adverse events are less likely to occur.”

to enhance the provision of care, improve clinical education and increase our capacity for research. We are delighted to sign

this agreement with St Patrick’s Mental Health Services to advance the clinical training of our pharmacy students.”

A First for Pharmacy The pharmacy department at St Patrick’s Mental Health Services has announced the signing of a memorandum of understanding (MOU) with Trinity College Dublin (TCD). The Memorandum of Understanding will enable St Patrick’s pharmacy and TCD to:

Professor Anne Marie Healy, Head of School, Trinity College Dublin, Ailish Young, Acting Chief Pharmacist, Professor Mary McCarron, Dean of Health Sciences and Mr Tom Maher, Director of Services

 Formally establish teaching, research, and clinical links;  Facilitate professional development in pharmacy;  Encourage research, and;  Work together for the provision of excellence in patient care. The Memorandum of Understanding was signed in the Board Room of St Patrick’s University Hospital by Director of Services, Tom Maher on behalf of St Patrick’s Mental Health Services, with Trinity being represented by the Dean of Health Sciences, Professor Mary McCarron. St Patrick’s Director of Services, Tom Maher said, “As the largest centre for post-graduate training of mental health professionals in Ireland, St Patrick’s Mental Health

Services has a long-standing commitment to training and education and well-established links with Trinity College. We welcome the opportunity to expand our offering by becoming formally involved in the TCD teaching programme for pharmacy students”. Speaking on the signing, the Dean of Health Sciences, Professor Mary McCarron, “The Faculty and the School are forging links with service providers such as St Patrick's University Hospital who share our determination

HPN • Professional Top100 - 2016


6 News

Maternity Hospital first to launch ehealth record Cork University Maternity Hospital has been the first to launch the electronic health record, with the first baby to be born in Ireland having their own record from birth.

Professor Richard Greene, Consultant Obstetrician, Cork University Maternity Hospital

This marks the introduction of Ireland's Maternal & Newborn Clinical Management System which will see the implementation of an electronic health record (EHR) for all women and babies in maternity services in Ireland. This allows the clinical record information to be shared with relevant providers of care, as and when required. Professor Richard Greene, Consultant Obstetrician, Cork University Maternity Hospital and MN-CMS Joint National Clinical Lead for Obstetrics, said, “This new clinical management system means that patients will have an electronic record instead of a paper record, which will enhance patient care. The system includes maternity early warning scores (iMEWS) and a sepsis early warning scoring system, eprescribing and order communication tools for mother and baby patient care. Neonatal

ICU has its first digital support solution to capturing of key information. This ‘go live’ is a result of the dedication and teamwork of many staff within maternity services nationally.” While the system went live in Cork Maternity Hospital, plans are in place to roll out the system across the country with the next implementation due to take place University Hospital Kerry followed by The Rotunda Hospital and the National Maternity Hospital.

The introduction of this new system in Ireland also marks the introduction of the first national electronic patient chart for maternity anywhere in the world. This means that every maternity hospital in one country will be using the same electronic chart with standardisation of the information flow and collection with very obvious advantages for the patient and carers. Mr Richard Corbridge, HSE’s Chief Information Officer and Chief Officer of eHealth Ireland said: “All babies from birth will now have their own digital health record. The MN-CMS is one of the strategic programmes within eHealth Ireland and its implementation will help to build a better healthcare service for mothers and babies.”

The HSE has a contract with Cerner to deliver the Maternal & Newborn Clinical Management System (MN-CMS) which will then be rolled out to all 19 maternity units over a three year period. The implementation of MN-CMS will be the first instance of any Electronic Health Record (EHR) system on a shared record basis in the Irish healthcare system. The system has been specifically tailored for the Irish healthcare system with clinicians completing a full clinical validation of the design and build of the MN-CMS. The record of both mother and baby can now be shared where appropriate throughout the maternity care pathway. Matthew Pickett, General Manager, Cerner Ireland said, “Cerner is proud to be partnered with the HSE in the creation of this new system which has been designed and built with extensive Irish clinical input, and specific to the needs of Ireland’s population and clinical community. This first implementation in Cork is an exciting step toward a national digitised health care system.”

Report on long term challenges for healthcare The European Commission's Directorate-General for Economic and Financial Affairs (DG ECFIN) has published a report on the common challenges faced by EU Member States in maintaining the financial sustainability of their health systems. The report includes a variety of recommendations for meeting these challenges, including for the hospital sector, and on the cost of pharmaceuticals. The report re-emphasises familiar themes such as the need to reduce unnecessary hospitalisations via strong primary care systems, and the need to invest in "cost -effective ICT and eHealth solutions which not only enable better coordination but provide a possibility for seamless integration". The report highlights common goals of EU health systems as being: > Shifting excessive activity of acute inpatient to outpatient care services; > Reallocating resources from inpatient to outpatient care, and; Professional Top100 - 2016 • HPN

> Improving the cost-efficiency of hospitals. Overall, in respect to hospital care, the report makes the recommendation, "The sustainability of hospital care should be enhanced by improving financing arrangements, through combination of activity-based payments, global budgets and pay-for-performance schemes, and by reducing operational costs, also through extending the use of centralised public procurement, price transparency and strengthening the fight against corruption, fraud and misuse of public resources. Systematic monitoring, comparison of hospital performance and benchmarking is key to improving the sector's performance. Policies should be deployed to reduce the demand for unnecessary emergency care.” The Ireland Market Statistics relevant to the Irish sector show that Ireland has a GDP per capita of 33.9 PPS (in thousands), far above the EU average of 27.9 Total expenditure (133) on health

as a percentage of GDP (8.9% in 2013) has increased over the last decade (from 7.3% in 2003, although it has decreased since the 2009 peak of 10%) but is still below the EU average (134) of 10.1% in 2013. Public expenditure has increased, though to a smaller extent: from 5.6% in 2003 to 6.0% of GDP in 2013. Again, it is below the peak of 7.2% in 2009. It is also below the EU average of 7.7% in 2013. When expressed in per capita terms, total current spending on health at 3156 PPS in Ireland is above the EU average of 2988 in 2013. However, public current spending on health care is, at 2136 PPS, lower than the EU average of 2208 PPS in 2013. The report highlights the below challenges:  To consider changes in payment procedures to physicians (e.g. through the use of mixed payment schemes) to encourage health promotion, disease prevention and disease management activities in primary care and make primary

care more attractive; To implement measures to prevent chronic diseases and their complications.  To reduce unnecessary use of specialist and hospital care and within hospitals, ensuring that care is provided in the most clinically appropriate and cost-effective way, for example by maximising the proportion of elective care provided on a day case basis, dayof- surgery admission and reducing inappropriate lengths of stay.  To explore the means to improve the way private and public provision are better integrated in an overall provision framework and reconsider the current system of payment incentives which may be detrimental to public patients and the public sector.  To consider additional measures regarding direct pharmaceutical expenditure control, product reimbursement on the basis of cost-effectiveness information and greater use of generics vs. branded medicines.


8 News 100% transparency is key - IPHA President of transfers of value. 100 per cent public disclosure is in the public interest. “We will continue to work cooperatively with all involved, including of course the Minster for Health, to achieve this.” New Agreement Ms Dickens also commented on the new Agreement reached between IPHA and the Government in summer. “Stability in supply, predictability in pricing, and a clear pathway for the adoption of new medicines: these are things that matter to the State and to our members and even more to patients who want, need and deserve the solutions that medicines provide Mr Billy Kelleher, T.D., Mary Dickens, President and Mr Oliver O’Connor, Chief Executive, IPHA

Addressing the 23rd Conference of the Irish Pharmaceutical Healthcare Association, its President, Mary Dickens declared that 100% transparency on support from the pharmaceutical industry to healthcare professionals was essential in the public interest. Under a new European voluntary code implemented by IPHA in Ireland, payments from

pharmaceutical companies to Healthcare Professionals and Healthcare Organisations have been disclosed since 300th June this year. Individual consent to disclosure is a right for each person under data protection law and not all healthcare professionals have chosen to give such consent this year. Ms Dickens said, “The doctors, pharmacists, nurses, other health

professionals and healthcare organisations we work with are at the forefront of patient care. The relationship between our industry and healthcare professionals helps them provide best patient care and helps our companies develop and provide medicines. “Our goal is to achieve 100% consent by Health Care Professionals and Health Care Organisations to public disclosure

“Already price reductions on hundreds of medicines have happened and savings are being made for the HSE budget. “Patients and their treating clinicians can expect that IPHA and the State authorities will make our Agreement work to deliver fast access to new medicines. The Agreement works if it brings new medicines to people. So we encourage the HSE, to include timely access to new medicines as a performance indicator alongside financial performance issues. Whilst few new medicines have been released since the agreement – we look forward to improvement in the process and timelines.”

COPD Support Ireland Patient Conference Marcella Corcoran Kennedy TD, Minister of State at the Department of Health with responsibility for Health Promotion opened the COPD Support Ireland Patient conference last month (November). “I welcome the close links between the HSE’s National Clinical Programme for COPD and COPD Support Ireland,” said the Minister. “The work of the National Clinical Programme to build improved services and treatment outcomes is continuing. Today, I want to bring some focus on how the programme is getting on with addressing the high rate of hospital admissions. “The Programme is putting Respiratory Integrated Care Professional Top100 - 2016 • HPN

Demonstrator services in place in our primary care settings,’ continued the Minister. ‘This means that Respiratory Clinical Nurse Specialists and Senior Physiotherapists are being appointed to deliver care and services in primary care. This is very positive and will specifically address the high rate of hospital admissions for people with COPD.” Earlier this year, Respiratory Clinical Nurse Specialists and Senior Physiotherapists were appointed in 4 locations with links to hospitals. And again this year 6 additional sites for the appointment of these specialist nurses and Senior Physiotherapists were funded by

the HSE. These 6 additional sites are also linked to a number of hospitals such as Mayo University Hospital, Galway University Hospital, Letterkenny, Tallaght, St James’s and Wexford. The recruitment of these health professionals is underway. The HSE expects that these posts will be filled by the end of this year. The Minister continued, “Of course, there is more to be done with respect to COPD. The HSE’s National Clinical Programme for COPD will always be cognisant of this. We are making progress.‘All of these actions taken together are important steps to develop services and care for people living with COPD.”

The National Clinical Programme for COPD (NCP COPD) was established in 2010 under the clinical leadership of Prof Tim McDonnell and guidance from the COPD Clinical Advisory Group, chaired by Prof Stephen Lane. The aim of the NCP COPD is to design and standardise the delivery of high quality care for patients with COPD in Ireland through a range of actions and initiatives including the development of services, clinical guidelines, Integrated models of Care, educational materials, initiatives to better integrate primary and secondary care and by engaging with key stakeholders in order to ensure better care for those with COPD.


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ULTIBRO® BREEZHALER® is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).5 * Patients had at least one moderate or severe exacerbation in the previous 12 months. † Patients had no moderate or severe exacerbation in the previous 12 months. ‡ Fluticasone/Salmeterol 500/50 mg BID. Ultibro Breezhaler ▼This This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions. ABBREVIATED PRESCRIBING INFORMATION Please refer to Summary of Product Characteristics (SmPC) before prescribing. Presentation: Ultibro® Breezhaler® 85mcg / 43mcg inhalation powder hard capsules containing indacaterol maleate and glycopyrronium bromide respectively and separate Ultibro® Breezhaler® inhaler.Indications: A maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Dosage and administration: Recommended dose is the inhalation of the content of one capsule once daily, administered at the same time of the day each day, using the Ultibro® Breezhaler® inhaler. Capsules must not be swallowed. No dose adjustment required in elderly patients, for patients with mild and moderate hepatic impairment or for patients with mild to moderate renal impairment. No data available for use in patients with severe hepatic impairment and should only be used in patients with severe renal impairment or end-stage renal disease requiring dialysis if the expected benefit outweighs the potential risk. No relevant use in the paediatric population. Contraindications: Hypersensitivity to the active substances or to any of the excipients. Warnings/Precautions: Not to be administered concomitantly with medicinal products containing other LABA’s or LAMA’s. Asthma: ♦ULTIBRO® BREEZHALER® SHOULD NOT BE USED FOR TREATMENT OF ASTHMA. Acute use: ♦Not indicated for treatment of acute episodes of bronchospasm. Hypersensitivity: ♦Immediate hypersensitivity reactions have been reported after administration of indacaterol or glycopyrronium. If signs suggesting allergic reactions occur (in particular, angioedema, difficulties in breathing or swallowing, swelling of the tongue, lips and face, urticaria or skin rash), treatment should be discontinued immediately and alternative therapy instituted. Paradoxical bronchospasm: ♦If paradoxical bronchospasm occurs, Ultibro® Breezhaler® should be discontinued immediately and alternative therapy instituted. Anticholinergic effects related to glycopyrronium: ♦To be used with caution in patients with narrow-angle glaucoma and in patients with urinary retention. Patients with severe renal impairment: ♦Should only be used in patients with severe renal impairment, including those with end-stage renal disease requiring dialysis, if the expected benefit outweighs the potential risk. These patients should be monitored closely for potential adverse reactions. Cardiovascular effects: ♦To be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension), in patients with known or suspected prolongation of the QT interval or patients treated with medicinal products affecting the QT interval and in patients with unstable ischaemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (excluding chronic stable atrial fibrillation), a history of long QT syndrome or whose QTc (Fridericia method) was prolonged. ♦LABA’s may produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, blood pressure, and/or symptoms, ECG changes. In case such effects occur, treatment may need to be discontinued. Hypokalaemia: ♦ LABA’s may produce significant hypokalaemia in some patients, which has the potential to produce cardiovascular effects. In patients with severe COPD, hypokalaemia may be potentiated by hypoxia and concomitant treatment which may increase the susceptibility to cardiac arrhythmias. Hyperglycaemia: ♦Inhalation of high doses of LABA’s may produce increases in plasma glucose. Upon initiation of treatment with Ultibro® Breezhaler® plasma glucose should be monitored more closely in diabetic patients. ♦ Ultibro® Breezhaler® has not been investigated in patients for whom diabetes mellitus is not well controlled. General disorders: ♦To be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to LABA’s. Excipients: ♦ Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Pregnancy and Lactation: ♦Ultibro® Breezhaler® should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the foetus. ♦Not known whether indacaterol, glycopyrronium and their metabolites are excreted in human milk. Use of Ultibro® Breezhaler® by breast-feeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant. Interactions: ♦Concomitant use is not recommended with beta adrenergic blockers, anticholinergics or sympathomimetic agents. ♦Concomitant hypokalaemic treatment with methylxanthine derivatives, steroids, or non-potassium-sparing diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists, therefore use with caution. ♦Inhibition of the key contributors of indacaterol clearance, CYP3A4 and P-gp, does not raise any safety concerns given the safety experience of treatment with indacaterol. ♦No clinically relevant drug interaction is expected when glycopyrronium is co administered with cimetidine or other inhibitors of the organic cation transport. Adverse reactions: ♦Very common: upper respiratory tract infection. ♦Common: nasopharyngitis, urinary tract infection, sinusitis, rhinitis, dizziness, headache, cough, oropharyngeal pain including throat irritation, dyspepsia, dental caries, gastroenteritis, musculoskeletal pain, pyrexia, chest pain. ♦Uncommon: hypersensitivity, angioedema, diabetes mellitus and hyperglycaemia, insomnia, paraesthesia, glaucoma, ischaemic heart disease, atrial fibrillation, tachycardia, palpitations, paradoxical bronchospasm, epistaxis, dry mouth, pruritus / rash, muscle spasm, myalgia, pain in extremity, bladder obstruction and urinary retention, peripheral oedema and fatigue. ♦Please refer to SmPC for a full list of adverse events for Ultibro® Breezhaler®. Legal Category: POM Pack sizes: Cartons containing 10 capsules (1x10 capsule blister strips) and one Ultibro® Breezhaler® inhaler or 30 capsules (3x10 capsule blister strips) and one Ultibro® Breezhaler® inhaler. Marketing Authorisation Holder: Novartis Europharm Limited, Frimley Business Park, Camberley GU16 7SR, United Kingdom. Marketing Authorisation Numbers: EU/1/13/862/007 & 003. Full prescribing information is available on request from Novartis Ireland Ltd, Vista Building, Elm Park Business Park, Dublin 4. Tel: 01 2601255 or at www. medicines.ie Date of Revision of API Text: 9th February 2016 References: 1. Wedzicha JA, Banerji D, Chapman KR, et al. Indacaterol–glycopyrronium versus salmeterol–fluticasone for COPD. N Engl J Med. 2016. 374:2222-2234. 2. Wedzicha JA, et al. Lancet Respir J 2013:1:199–209. 3. Mahler DA, et al. Eur Respir J 2014;43:1599–1609. 4. Vogelmeier CF, et al. Lancet Respir Med; 2013:1:51–60. 5. Ultibro® Breezhaler®. Summary of Product Characteristics. Accessed on www.medicines.ie, October 2016.

Date of Preparation: October 2016 IE02/ULT16-CNF057q


10 News

Study finds new cardiovascular predictor of mortality in older people The team at Trinity College Dublin in collaboration with researchers from Harvard University’s Centre for Population and Development Studies found that the speed of heart rate recovery in the initial 20 seconds after a person stands predicts the likelihood of dying over four years in older people.

Trinity in 2011. The research team then followed up four years later. Participants in the study rested in a lying position for 10 minutes during which time their heart rate and blood pressure were monitored. Participants were then asked to rise from the lying position to a standing position [Figure 1].

The research team went a step further by dividing participants into groups based on their speed of heart rate recovery. Those in the slowest heart rate recovery group were 7 times more likely to die over the four year period compared with those in the fastest heart rate group. They remained 2.3 times more likely to die even when the researchers took account of other known risk factors for mortality and for heart rate such as age, diabetes, lung disease, socioeconomic status, smoking, dietary factors, and body mass index.

This simple maneuver represents a major cardiovascular challenge causing the heart to beat faster as it tries to compensate for the drop in blood pressure that occurs when a person stands up after lying down. The heart beat then returns towards its baseline or normal rate and it is the speed of this recovery to baseline that is the key factor. The faster it returns to normal, the better.

The research involved 4475 TILDA respondents aged 50 years and over who completed a detailed cardiovascular health assessment at the TILDA health centre at

Figure 1 shows the average heart rate and blood pressure response to standing among 4475 participants who completed the active stand in The Irish Longitudinal Study on Ageing (TILDA). The vertical axis represents values of heart rate in beats per minute (bpm) and values

Figure 1

of systolic and diastolic blood pressure in millimeters of mercury (mmHg). Resting values of heart rate and blood pressure were measured 60 seconds prior to standing. Heart rate rises rapidly in the initial 10 seconds after standing to combat the drop in

blood pressure that occurs when a person stands from a lying position. The speed of heart rate recovery (i.e. decline in heart rate) between 10 and 20 seconds after standing predicts an individual’s risk of mortality over a four-year period.

Pearl in Ireland’s Medicines Oyster Ireland is at the centre of a new Pharmacy Network, with the aims of achieving earlier patient access to new medicines. The UCC School of Pharmacyled PEARRL (Pharmaceutical Education and Research with Regulatory Links) Network officially launched last month. PEARRL (Pharmaceutical Education And Research with Regulatory Links) is a European Training Network (ETN) for innovative drug formulation strategies and biopharmaceutics tools with regulatory application. The PEARRL ETN brings together 18 leading European institutions and is co-ordinated by Dr Brendan Griffin from the School of Pharmacy, University College Cork (UCC). The programme is funded (¤ 4 million) under the European Union’s Horizon 2020 research and innovation programme (Marie Sklodowska-Curie actions). Dr Griffin says, “Within PEARRL, our research will develop novel drug delivery technology, new

Professional Top100 - 2016 • HPN

screening methods and innovative models to forecast drug levels in humans, which will collectively streamline the development of new oral medicines. In addition, PEARRL will provide a unique training network for developing the next generation of leading pharmaceutical and regulatory scientists.” From antibiotics through medicines which prevent gastric ulcers to stem cell research, the research in the pharmaceutical sciences has made great strides over the last century. Whereas average life expectancy was under 40 years at the beginning of the 20th century, the worldwide average today is around 70 years of age. Medical breakthroughs have contributed to not only longer life expectancy but also by a lower infant mortality rate and higher quality of life for the elderly. However, developing a new drug is a long, costly and complex process and every step of it is has to be carefully reviewed. Drug development requires many

Dr Brendan Griffin, Senior Lecturer, School of Pharmacy, UCC

meet the stringent requirements expected by regulatory authorities such as the European Medicines Agency (EMA) and therefore not be approved and become available to patients.

different disciplines such as medicine, pharmacology, chemical engineering or bioinformatics working hand in hand. Even so, at the end of the long process of drug development – often over 10 years - and after consuming considerable human and financial resources, the new drug’s safety and efficiency in the targeted patient population may not

The main research objectives of PEARRL are to develop novel bio-enabling formulations (“better drugs”), new biopharmaceutics tools and predictive in silico methods to forecast drug levels in humans (“streamlined development”), which together will serve as communication bridgers between research and regulatory science (“accelerated approval”), thus improving the efficiency and cost-competitiveness of pharmaceutical R&D. The key impact will be that new medicines will be brought to the market faster, and at reduced cost, therein facilitating earlier access of patients to breakthrough therapies.


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1. SmPC Vitaros Abbreviated PI Presentation Single use AccuDose container containing alprostadil cream (3mg/g) Indication Erectile dysfunction Dosage Each patient should be instructed by a medical professional prior to self-administration. Apply contents of container (300mcg) to tip of penis 5-30 minutes before intercourse. Do not insert tip of container into urethral meatus. Rub any excess cream into surrounding area. Do not use more than 2-3 times/week and once only in a 24hr period. Contraindications Hypersensitivity to ingredients, orthostatic hypotension, myocardial infarction and syncope. Predisposition to priapism, eg sickle cell anaemia, thrombocythemia, polycythemia, multiple myeloma, leukaemia. Abnormal penile anatomy, urethritis, balanitis. Prone to venous thrombosis, hyperviscosity syndrome, unstable cardiovascular or cerebrovascular conditions. Use a condom for intercourse with a woman of child-bearing potential. Precautions and Warnings If priapism occurs seek immediate medical assistance. Avoid activities such as driving or hazardous tasks where injury could result from syncope or hypotension. Interactions Drug-drug interactions are unlikely. There are no data on concomitant use with other PDE5 inhibitors but avoid the combination. Concomitant use of antihypertensives and vasoactive drugs may show an increased risk of hypotension, especially in the elderly. Pregnancy and lactation No data. Pregnant women should not be exposed to Vitaros. Not recommended while breastfeeding Side effects common rash, urethral pain, penile oedema, pain and altered sensations. Genital erythema, discomfort and itch, balanitis. uncommon hyperaesthesia, dizziness, syncope, hypotension, pain in extremity, urethral stenosis, urinary tract inflammation, excessive rigidity/priapism, vulvovaginal itch/discomfort and vaginitis in partner, application site pain. Pack size 4 units Legal category POM MA holder Recordati Ireland Ltd. Raheens East, Ringaskiddy Co. Cork, Ireland MA Number PA1404/003/002 Date of First Authorisation/Renewal of the Authorisation –Date of first Authorisation: 9th October 2015 Date of Preparation March 2016 For full prescribing information please see summary of product characteristics For Medical Information please contact 1800303351.

CMYK


12 Review: European Pharmacy

Dealing with a Hospital Evolution Joan Peppard, President, EAHP

The hospital environment is in a constant state of evolution. In recent times these changes have been intense, especially in light of the financial crisis with hospital budgets being significantly reduced and a greater emphasis on patient outcomes. Challenges also include demographic change which means hospitals are faced with the demands of an ageing population along with the newer challenge of obesity related diseases. At the same time patient expectations are increasing and the complexity of medication management continues to grow. The challenge to provide pharmacy services to the level required for each patient to meet their needs is a test for each healthcare service and hospital pharmacist. EAHP supports the achievement of improved patient outcomes through the actions of hospital pharmacists, by advocating at the European level, by sharing best practice at national and European level and through education. Hospital pharmacists have the skill set to contribute to the challenge of improving patient outcomes alongside our pharmacist colleagues in community and primary care. Working in collaboration with all healthcare professionals as part of the multidisciplinary team the hospital pharmacist is well placed to provide the expertise and support required to achieve the desired patient outcomes. The 44 European Statements of Hospital Pharmacy were developed and published following an 18 month multi-stakeholder consultation process in 2014. These Statements describe the commonly agreed objectives which every European health system should aim for in the delivery of hospital pharmacy

Professional Top100 - 2016 • HPN

services to optimise patient outcomes. The overarching goal describes hospital pharmacists working collaboratively within multidisciplinary teams in order to achieve the responsible use of medicines across all settings. Healthcare systems in Europe are complex with different approaches to the organisation, financing and delivery of health services and healthcare systems are the responsibility of each member country. As a consequence of historical factors hospital pharmacy services, including management of transitions of care, vary considerably with no two countries having the same approach or at the same level of development in all aspects of practice. EAHP has surveyed its members who have identified capacity and capability as the two major barriers to achieving the goal of the Statements. EAHP is working to support Hospital Pharmacists to meet the capacity and capability challenges identified in the surveys. On capability, EAHP is undertaking a number of actions to increase the knowledge of individual pharmacists through education via the EAHP Congress , Academy seminary with a train the trainer model, the European Journal of Hospital Pharmacy, as well as a website of good practice initiatives. This website is a resource to inspire and encourage fellow hospital pharmacists in other countries to strive for the next high standard in practice. This website identifies how colleague hospital pharmacists were able to overcome barriers and obstacles in order to make improvement happen in their hospitals. An amendment to the European Professional qualifications directive gives an opportunity

to EAHP to address a long held goal of the members – to seek mutual recognition of the hospital pharmacist as a specialist. Seven EU countries already have legal recognition for hospital pharmacy specialisation. EAHP is developing a framework of competencies that describes the behaviour, attitude and beliefs of the hospital pharmacist specialist and will consult on this framework in early 2017 with the goal of achieving mutual recognition. On capacity, it is clear that there is much outside the scope of health systems, such as austerity and demographics, which influence the need for, and delivery of, healthcare. EAHP has established a members’ forum to demonstrate and focus on the benefit investment in hospital pharmacy services can bring in achieving the healthcare goals set in each member state. EAHP will continue to support hospital pharmacists to explain the benefits of hospital pharmacy services and work to increase demand for pharmacy services by patients, healthcare professionals and managers. The slow investment in, and lack of interconnectivity of, healthcare systems present a challenge to seamless pan-European healthcare delivery. President Ilves (Estonia) in an address to the European parliament in February 2016 said, "Yet, sector-by-sector, our legislation remains fractured between Member States and unprepared for the digital age." For hospital pharmacists managing transitions of care the lack of interconnectivity may be a local issue within hospitals systems or a lack of connectivity with primary and community care systems. Care transitions may be internal to the hospital as a patient moves from the ward to theatre, to ICU, or externally as the patient returns to the home or residential care environment. A dependence on manual systems or systems that do not connect increases the risk for patients navigating our healthcare systems and needs to be urgently addressed. At the same time hospital pharmacists in all EU and European Economic Area (EEA) countries need to take time to familiarise themselves with the forthcoming impact to practice arising from the 2011 Falsified Medicines Directive and ensure

hospital pharmacy representation at the national level on the issue. The Directive will bring about a new system in which all packages of medicine will be given a ‘unique identifier’ via a two-dimensional (2D) barcode on the outer packaging. Importantly for hospital pharmacy, this code must then be ‘checked out’ at the end of the supply chain, before the medicine is dispensed or administered to patients. This scan both assures the pharmacist that the product is not counterfeit, while the ‘check out’ ensures the 2D barcode cannot be reused by counterfeiters. In practice, this means the hospital pharmacy will need to change processes to ‘checkout’ every package of medicine entering a hospital. The deadline for implementation is 19 February 2019. EAHP links with other healthcare agencies to address longstanding challenges to health such as medication shortages, antimicrobial resistance, and appropriate use of new technologies in the health sphere. An example of the latter is our participation in European Commission projects on encouraging the application of mHealth technologies. Finally, EAHP will always be highly responsive to all emerging developments in the field of medicines regulation at the European level. This includes being an active stakeholder to the European Medicines Agency, and ensuring the hospital pharmacist perspective and experience is understood in emerging areas of regulatory debate such as orphan drug, paediatric and off-label regulation. In all that we do, EAHP will always have in mind its guiding mission of ensuring the continuous improvement of care and outcomes for patients in the hospital setting. As WHO patient advocate Margaret Murphy reminds us: ‘the patient is the individual with the greatest vested interest in the outcome.’ Joan Peppard is Chief Pharmacist at Midland Regional Hospital, Tullamore and is President of the European Hospital Pharmacists Association.


BE THE

ONE WHO CAN CHANGE WHAT’S POSSIBLE FOR HCV GT1 ADULT PATIENTS1

HARVONI® – Make cure a reality for the majority of your GT1 patients1–4 In clinical trials of compensated hepatitis C (HCV) patients: • Upto 99% Cure 1-4 •

94–97% of treatment-naïve, non-cirrhotic patients cured with 8 wks*1,4

99% of treatment-naïve patients cured with 12 wks2

94–99% of treatment-experienced patients cured with 12–24 wks 3

• 8 weeks may be considered for treatment-naïve, non-cirrhotic patients1 •

One pill once a day1

• Small number of clinically relevant DDIs1** Compensated cirrhosis, decompensated cirrhosis and post-transplant patients may require the addition of RBV 1

Albert Einstein used with permission of the HUJ/GreenLight.

*97% relates to the SVR for patients with a viral load of less than 6 million IU/ml

HARVONI is indicated for the treatment of chronic hepatitis C infection in adults1 ®

PRESCRIBING INFORMATION Consult the Summary of Product Characteristics before prescribing.

90mg ledipasvir/400mg sofosbuvir film coated tablets. HARVONI® Indications: For the treatment of chronic hepatitis C (CHC) in adults. Dosage & Administration: Adults: One tablet, taken orally, once daily with or without food. Genotype 1, 4, 5 or 6; without cirrhosis: 12 weeks of treatment with Harvoni is recommended. 8 weeks may be considered in previously untreated genotype 1-infected patients. Harvoni + ribavirin for 12 weeks or Harvoni (without ribavirin) for 24 weeks should be considered for previously treated patients with uncertain subsequent retreatment options. Genotype 1, 4, 5 or 6; with compensated cirrhosis: Harvoni + ribavirin for 12 weeks or Harvoni (without ribavirin) for 24 weeks of treatment with is recommended. Harvoni (without ribavirin) for 12 weeks may be considered for patients deemed at low risk for clinical disease progression and who have subsequent retreatment options. Genotype 1, 4, 5 or 6; post liver transplant without cirrhosis or with compensated cirrhosis: Harvoni + ribavirin for 12 weeks. Harvoni (without ribavirin) for 12 weeks (in patients without cirrhosis) or 24 weeks (in patients with cirrhosis) may be considered for patients who are ineligible for or intolerant to ribavirin. Genotype 1, 4, 5 or 6; with decompensated cirrhosis: Harvoni + ribavirin for 12 weeks. Harvoni (without ribavirin) for 24 weeks may be considered in patients who are ineligible for or intolerant to ribavirin. Genotype 3 with compensated cirrhosis and/or prior treatment failure: 24 weeks treatment with Harvoni in combination with ribavirin is recommended. Please refer to the SmPC for recommended dose & treatment duration for combination therapy. When used in combination with ribavirin, refer also to the SmPC of ribavirin. Refer to the individual SmPCs for additional information regarding dose modifications & discontinuations. Renal impairment: Mild or moderate renal impairment: no dose adjustment required. Severe renal impairment or end stage renal disease (ESRD) requiring haemodialysis: not recommended. Refer to the SmPC for ribavirin for patients with creatinine clearance (CrCl) < 50 mL/min. Hepatic impairment: Mild, moderate or severe hepatic impairment: no dose adjustment required. Safety and efficacy of Harvoni have been established in patients with decompensated cirrhosis. Children and adolescents: The safety and efficacy of Harvoni in children & adolescents aged <18 years have not yet been established. Elderly: No dose adjustment is warranted for elderly patients. Contraindications: Hypersensitivity to the active substance or to any excipients. Use with potent P-gp inducers (in the intestine; rifampicin, rifabutin, St. John’s wort [Hypericum perforatum], carbamazepine, phenobarbital and phenytoin) will significantly decrease ledipasvir & sofosbuvir plasma concentrations and could result in loss of efficacy of Harvoni. When Harvoni is used in combination with ribavirin, contraindications applicable to that agent is applicable to combination therapies. Refer to the ribavirin SmPC for a list of contraindications. Warnings and Precautions: Harvoni should not be administered concomitantly with other medicinal products containing sofosbuvir. The clinical data to support the use of Harvoni in HCV genotype 2, 3 and 6 patients are limited. A conservative 24 weeks of therapy is advised in all treatment-experienced genotype 3 patients and those treatment-naïve genotype 3 patients with cirrhosis. Severe bradycardia and heart block: Cases of severe bradycardia and heart block have been observed when Harvoni is used with concomitant amiodarone with or without other drugs that lower heart rate. The  mechanism is not established. Should concomitant use of amiodarone be considered necessary, it is recommended that patients are closely monitored when initiating Harvoni. All  patients receiving Harvoni in combination with amiodarone with or without other drugs that lower heart rate should be warned of the symptoms

**Drug-drug interaction

Cure defined as SVR12

1. HARVONI® SmPC available at https://www.medicines.org.uk/emc/medicine/29471 (Accessed June 2016) 2. Afdhal N et al. N Engl J Med 2014;370:1889–1898. 3. Afdhal N et al. N Engl J Med 2014;370:1483–1493. 4. Kowdley KV et al. N Engl J Med 2014;370:1879–1888. 5. Gilead Data On File – SOFUK1601 (February 2016)

of bradycardia and heart block and should be advised to seek medical advice urgently should they experience them. Patients who are identified as being high risk of bradyarrhythmia should be continuously monitored for 48 hours in an appropriate clinical setting. Due to the long half-life of amiodarone, appropriate monitoring should also be carried out for patients who have discontinued amiodarone within the past few months and are to be initiated with Harvoni. Treatment of patients with prior exposure to HCV directacting antivirals: There are no data to support the effectiveness of retreatment of patients who have failed Harvoni with a subsequent regimen that contains an NS5A inhibitor. Consideration should be given to longer treatment for patients with uncertain subsequent retreatment options. Patients with decompensated cirrhosis and/or who are awaiting liver transplant or post-liver transplant: The efficacy of Harvoni in genotype 5 and 6 with decompensated cirrhosis and/ or who are awaiting liver transplant or post-liver transplant has not been investigated. Treatment with Harvoni should be guided by an assessment of the potential benefits and risks for the individual patient. Use with moderate P-gp inducers: Medicinal products that are moderate P-glycoprotein (P-gp) inducers in the intestine (e.g. oxcarbazepin) decrease ledipasvir and sofosbuvir plasma concentration leading to reduced therapeutic effect of Harvoni. Co-administration is not recommended. Use with certain HIV antiretroviral regimens: Harvoni has been shown to increase tenofovir exposure, especially when used together with an HIV regimen containing tenofovir disoproxil fumarate and a pharmacokinetic enhancer (ritonavir or cobicistat). The safety of tenofovir disoproxil fumarate in this setting has not been established. The potential risks and benefits associated with co-administration of Harvoni with the fixed-dose combination tablet containing elvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil fumarate or tenofovir disoproxil fumarate given in conjunction with a boosted HIV protease inhibitor (e.g. atazanavir or darunavir) should be considered, particularly in patients at increased risk of renal dysfunction. Patients receiving Harvoni concomitantly with elvitegravir/cobicistat/emtricitabine/ tenofovir disoproxil fumarate or with tenofovir disoproxil fumarate and a boosted HIV protease inhibitor should be monitored for tenofovir-associated adverse reactions. Refer to the SmPCs of the aforementioned agents for recommendations on renal monitoring. Use with HMG-CoA reductase inhibitors: Co-administration of Harvoni and HMG-CoA reductase inhibitors (statins) can significantly increase the concentration of the statin, which increases the risk of myopathy and rhabdomyolysis. HCV/HBV co-infection: There are no data available. Excipients: Harvoni contains sunset yellow FCF aluminium lake (E110), which may cause allergic reactions. It also contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take Harvoni. Interactions: Harvoni should not be administered concomitantly with other medicinal products containing sofosbuvir. Ledipasvir is an in vitro inhibitor of drug transporter P-gp and breast cancer resistance protein (BCRP) and may increase intestinal absorption of co-administered substrates for these transporters. Ledipasvir may be a weak inducer of metabolising enzymes such as CYP3A4, CYP2C and UGT1A1. Compounds that are substrates of these enzymes may have decreased plasma concentrations when co-administered with Harvoni. In vitro ledipasvir inhibits intestinal CYP3A4 and UGT1A1. Medicinal products that have a narrow therapeutic range and which are metabolised by these isoenzymes should be used with caution and carefully monitored. Ledipasvir and sofosbuvir are substrates of drug transporter P-gp and BCRP while GS-331007 is not. Refer to the Contraindication & Warnings & Precautions for P-gp inducers (in the intestine). Co-administration with medicinal products that inhibit P-gp and/or BCRP may increase ledipasvir and sofosbuvir plasma

concentrations without increasing GS-331007 plasma concentration; Harvoni may be co-administered with P-gp and/or BCRP inhibitors. Refer to SPC for full information regarding interactions. Pregnancy & lactation: When Harvoni is used in combination with ribavirin; extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin. Women of childbearing potential or their male partners must use an effective form of contraception during treatment and for a period of time after the treatment has concluded as recommended in the SmPC for ribavirin. Refer to the SmPC for ribavirin for additional information. There are no or limited amount of data (<300 pregnancy outcomes) from the use of ledipasvir, sofosbuvir or Harvoni in pregnant women. As a precautionary measure, it is preferable to avoid the use of Harvoni during pregnancy. Harvoni should not be used during breast-feeding. See also the SmPC for ribavirin for pregnancy and breast-feeding. Side effects: When Harvoni was studied with ribavirin, the most frequent adverse drug reactions to Harvoni in combination with ribavirin were consistent with the known safety profile of ribavirin, without increasing the frequency or severity of the expected adverse drug reactions. The following adverse drug reactions have been identified with Harvoni. Frequencies are defined as follows: Very commonly reported adverse events (≥1/10): headache and fatigue. Description of selected adverse reactions; Cardiac arrhythmias: Cases of severe bradycardia and heart block have been observed when Harvoni is used with concomitant amiodarone and/or other drugs that lower heart rate. Legal Category: POM. Package Quantities: Bottle of 28 film-coated tablets. Price: UK NHS Price - £12,993.33; Eire Price - €TBA Marketing Authorisation Number: EU/1/14/958/001 Further information is available from the local representative of the marketing authorisation holder: Gilead Sciences Ltd, 280 High Holborn, London, WC1V 7EE, UK. Telephone: +44 (0) 8000 113700, For Ireland: +353 214 825 999. E-mail: ukmedinfo@gilead.com. Harvoni is a trademark. Date of PI preparation: April 2016: HAR/UK/15-11/MM/1992(2)

▼ This medicinal product is currently subject to additional monitoring. Reporting suspected adverse reactions after

authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse reactions to Harvoni should be reported to Gilead via email to safety_FC@gilead.com or by telephone +44 (0) 1223 897500. Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Suspected adverse reactions should be reported to the HPRA Pharmacovigilance using a Yellow Card obtained either from the HPRA, or electronically via the website at www.hpra.ie. Adverse reactions can also be reported to the HPRA by calling +353 1 6764971.

© 2016 Gilead Sciences, Inc. All rights reserved. Date of preparation: June 2016 HAR/UK/14-11/MI/1033(7)


14 Review: HPAI

Evolving face of Hospital Pharmacy The Hospital Pharmacists’ Association of Ireland (HPAI) is a voluntary organisation that represents its members on issues relevant to hospital pharmacy. The hospital Pharmacists Association of Ireland exists to: • further the development of hospital pharmacy practices. • assist in the provision of continuing pharmaceutical education. • represent the views of the hospital pharmacist on issues of relevance to hospital pharmacy. • advance the professional welfare of our members. The HPAI was established as a professional voluntary group under the IMPACT trade union. IMPACT provides advice and support on issues of employee relations and negotiates at a national level for the welfare of hospital pharmacists. HPAI members may be elected to the national executive committee, and sub-committees are established under this as required. Examples of sub-committees include the education sub-committee, pharmacy software subcommittee, career structure sub-committee. A number of affiliated special interest groups hold regular meetings throughout the year and network closely to exchange information. These include the Irish Antimicrobial Pharmacists’ Group (IAPG), the Aseptics Special Interest Group (ASIG). The Critical Care Special Interest Group, the Cardiology Special Interest Group, the Medicines Information Special Interest Group. HPAI hosts a variety of educational activities each year for its members. These include the annual education conference in April, clinical skills courses at two levels, which equip the student with the basic skill sets to work as a clinical pharmacist, develop an understanding of evidence-based medicine and provide them with a framework for conducting their own research, aseptics meetings, open to pharmacists and pharmacy technicians, study days organised by individual special interest groups within the HPAI, and communication training days.

Professional Top100 - 2016 • HPN

The implementation of FMD and compliance with FMD will present very significant challenges to the hospital pharmacy sector. Engagement with senior management in the HSE, the private hospitals group and the Department of Health must be a priority here. HPAI provides forums on the HPAI website where members may exchange information and participate in discussions relevant to hospital pharmacy. There have been a number of recent developments and issues in hospital pharmacy in Ireland, and the evolving face of healthcare provides many exciting challenges and opportunities for both the individual hospital pharmacist and the profession as a whole. This year, the Irish Institute of Pharmacy (IoIP) started to inspect pharmacists’ evidence of CPD through their on-line portfolios. The HPAI strongly supports CPD for hospital pharmacists and is a key provider and facilitator of CPD. The clinical care programmes have been established and several have hospital pharmacists on board, advocating for the effective, evidence-based, safe and economical use of medicines in our patients. The eHealth strategy and ecosystem was launched by the Chief Information Officer in the HSE, Richard Corbridge, in 2015. There has been an increasing focus on ePharmacy as an area ripe for development, which will improve patient care, realise efficiencie and result in better transfer of patient information within and between healthcare providers. Also, in the area of medicines management ICT, the NCCP is developing a medical oncology clinical information system (MOSIS). The Falsified Medicines Directive programme has proceeded swiftly, with the formation and progress of the Irish Medicines Verification Organisation (IMVO)

under the auspices of the panEuropean equivalent. However, the implementation of FMD and compliance with FMD will present very significant challenges to the hospital pharmacy sector, given the type of workflows, the volumes of bulk-dispensed hospital medicines and the poor ICT infrastructure in most Irish hospitals. Engagement with senior management in the HSE, the private hospitals group and the Department of Health must be a priority here. The HPAI continue to meet regularly with the Pharmaceutical Society of Ireland to discuss issues relevant to the practice of hospital pharmacy in Ireland. The HPAI welcomes the publication of the PSI Charter – You and Your Pharmacist, and looks forward to a Charter for Hospital Pharmacists. PSI standards for the inspection of hospital pharmacies are awaited and 2016 also saw the signing of a Memorandum of Understanding between the PSI and the Healthcare, Information and Quality Authority (HIQA). In 2017, the private hospitals will also come under the remit of HIQA for inspection purposes. Staffing continues to be a challenge, in particular at the level of basic grade pharmacist, as graduates saw very significant salary cuts under FEMPI, with the mid-scale starting point abolished at this time. Graduate pharmacists are very poorly remunerated and the recruitment of basic grade pharmacists is difficult. It is unclear when this anomaly will be resolved. Although the generic HSE recruitment embargo has been lifted, hospital pharmacies still report delays and difficulties in filling vacant positions in a timely

manner. Staffing levels between different hospitals continues to vary widely. It remains to be seen what effect Brexit and the drive to recruit consultant pharmacists for primary care in the NHS, will have on the supply of hospital pharmacists in the Republic. The Report on the Review of Hospital Pharmacy, and the agreed career restructure for hospital pharmacists, published in 2012, is the subject of on-going discussions with the Department of Health and the HSE. 2016 saw the implementation of standardised annual leave arrangements for hospital pharmacy, along with other healthcare professionals. However, despite input from HPAI and IMPACT, some hospitals have yet to agree the implementation of this. 2016 saw a shortage of compounded chemotherapy for our patients, due to a supplier quality control issue, which required intervention on the part of the HSE, HPRA, and NCCP. Although there are no current issues, capacity remains a concern, in particular, given the recent departure of one of the two suppliers from the Irish market. 2016 also saw the first intake of the 5-year integrated MPharm students into our universities. The experiential model of learning is strongly supported by the HPAI, and many of our members have participated extensively in undergraduate education and training in previous years. However, the availability of positions for student hospital placements will be a challenge in future years. The HPAI is a member organisation of the European Association of Hospital Pharmacists (EAHP) and participates at a European level in various ways. In 2014, the EAHP published the European Statements of Hospital Pharmacy, agreed among all member states; these together form the commonly agreed expression for what every European health system should achieve in the delivery of hospital pharmacy services. Fionnuala Kennedy is Chief II Clinical Pharmacy Manager at St Vincent’s University Hospital and President of the Hospital Pharmacists Association of Ireland.


Review: eHealth 15

The year of the Digital Challenge If healthcare systems were to choose a representation of the year in the same way as the Chinese new-year has a symbol then 2017 in Ireland would be the year of the digital challenge! Since 2014 the eHealth Ireland agenda has been progressing, laying foundations, making some changes to facilitate the leap that the digital agenda can bring to healthcare. Those foundations in 2016 have brought some reward, eReferral and the Individual Health Identifier spring to mind immediately but so does the new structures the HSE has put in place to deliver technology, a single helpdesk across the country for example. The team have been clear in describing the eHealth Ireland journey at a great number of events in 2016, the two clear messages have been, this is a long journey, a continuing evolution not a big-bang and that the Irish healthcare system is ready to adopt a principle that there are no more IT projects, that what is being done by eHealth Ireland is in fact a huge, maybe the biggest in Ireland, business change programme. A key lesson for Ireland as it attempts to make this change though can be taken from the Choluteca Bridge in Honduras. A wonderful feat of Japanese engineering ingenuity and design, the bridge was completed in the late 1990â&#x20AC;&#x2122;s, unfortunately just before Hurricane Mitch devastated the Caribbean area. In November 1998, Hurricane Mitch ravaged the Honduras. 5,600 people died. 12,300 were injured and 8,600 disappeared. In addition to the loss of human life, 150 bridges were damaged or destroyed. The most modern of all the bridges, The Choluteca Bridge survived intact but suffered perhaps the greatest indignity, the river moved right out from under it leaving its builders wondering what to do next. This bridge was the only bridge left standing after the storm swept through. The Japanese company that built the bridge was so proud of it that a picture was put in their brochures of the bridge still standing firm but with the river moved some distance beyond its reaches.

Richard Corbridge, CIO, HSE

There is a key lesson for eHealth Ireland from this story, foundations have been considered, benefits released from some of these foundations, but as we move forward into 2017 and beyond we need to remain mindful of all that is happening around in the healthcare system, even the unexpected if we can. The delivery of an electronic health record (EHR) still has to be the ultimate goal for the programme of work. Maternity hospitals across Ireland will be of significant focus in 2017, not just as a readiness for the EHR itself but to ensure that a higher grade of digital maturity can be achieved to enable each hospital to deliver a single, patient contextualized model of care throughout Ireland. The eHealth Ireland team in partnership with the RCSI will also continue to focus on the delivery of a truly modernized model of care for patients with epilepsy, in 2017 the Irish EHR for epilepsy will be the first in the world to also allow the sequenced genome of consented patients to be viewed as part of the electronic health record, truly changing the way care is planned and developed. One of several long awaited projects for Ireland is the Medical Oncology Clinical Information System (MOCIS) solution; this solution has now been selected and will be awarded before the end of 2016. The solution has the capacity to provide an electronic record for Oncology and Haematooncology patients receiving Systemic Anti-Cancer Therapy.

Work will commence in 2017 to define the national design for the solution ensuring it is a digital solution that meets the need of care delivery in Ireland. Clinical validation of solutions is a route that Ireland has taken to ensure that systems are grounded in the business change and benefits delivery and not the specifics of the technology solution. Medication reconciliation after an admission or outpatient appointment will also be a focus of 2017. Access to a Summary Care Record with lists of medications dispensed in the community will be a good start to reduce clinical risks for patients as they move from care setting to care setting. Also opportunity to capture hospital derived scripts electronically under a wider ePrescribing initiative will provide a wealth of data not seen before in the Irish healthcare system. Hi-Tech mediations cost over ¤600m per annum alone and are still hand written in Ireland which makes audit more difficult and initiatives to make the process more efficient almost impossible. A world class initiative from Crumlin hospital that has seen them deploy digital SMART pumps is something that eHealth Ireland is keen to look at for all 18 possible sites in Ireland. The availability of this solution will significantly reduce clinical risk for babies and children in all acute settings. This project requires two elements in order to see it deployed. Clinical governance and small recurring investment 0.2 WTE Pharmacist, a national clinical trainer, and 3rd

party support for updating pumps on all sites. The business case to do this is now being developed. Modern technologies are key! Utilising automation and intelligent systems will improve the entire medication administration process from the way medications can be prescribed, dispensed to how medicine is given to patients. In 2017 a full business case will be developed for ePharmacy as a programme of work, this will be developed in conjunction with the department of health, for the first time the two organisations will work together to create the case for change and investment in a single area, the department of health and the HSE working in collaboration to ensure that the business change across pharmacy and medication management is possible. So, in the year of the healthcare digital challenge we can expect even more to happen than in 2016. We will see both the tangible frontline benefits of key specific EHR solutions, we will also be able to see the solid foundations for the years to come being put down, a long term strategy and more importantly an actual plan that enables the healthcare system of Ireland to hold eHealth Ireland as a programme to account, to celebrate success and to assist in ensuing that risks do not become issues. Richard Corbridge is the Chief Information Officer for the HSE.

HPN â&#x20AC;˘ Professional Top100 - 2016


16 Review: NAHPT

NAHPT – A Year in Focus The 2016 Committee of the National Association of Hospital Pharmacy Technicians

Orla O Shea, Laura Daly and Claire Keane was highly commended. The student winner was Ciara Rowan from Dublin Institute of Technology. The final presentation of the day was given by Kathleen Smith and Susan Duffy, Pharmacy Dept., Our Lady of Lourdes Hospital, Drogheda. They presented an overview of their winning poster from last year’s conference, “Topup Tweaking Tech Releasing”. On the evening of the 19th of May the NAHPT, in conjunction with the IACPT, welcomed our European colleagues for the annual EAPT (European Association of Pharmacy Technician) meeting which took place in the Hilton Hotel, Kilmainham. Twelve countries attended, Norway, Sweden, Finland, Denmark, UK, Ireland, Portugal, France, Germany, Serbia, Slovenia and Croatia and both Hospital and Community Pharmacy Technicians are represented. We had a presentation from Joan Peppard, President, European Association of Hospital Pharmacists, on the Saturday. She gave us an overview of the EAHP and their present goals. Joan’s presentation gave us food for thought now that the EAPT is a registered association. We continue to gather information on the role of Pharmacy Technicians in a number of areas including education, skills and competencies. An EAPT newsletter is in the planning process which will have some interesting articles from the other member countries. We had a very productive and successful meeting and our continued participation with our European colleagues can help our professional profile in Ireland and keep us in touch with Europe. The 2017 meeting will be held in Copenhagen.

Professional Top100 - 2016 • HPN

Writing effectively is becoming an important skill as all pharmacy staff are involved in writing SOPs, Memorandums and general correspondence on a daily basis. In April we held our Annual conference, ‘Stronger Together’ in the Crowne Plaza, Santry. The topics of our talks and workshops were Pain, Dermatology, Effective writing and the EAPT. John Lindsay, Chairperson, Chronic Pain Ireland gave an insight into the minds of people suffer from chronic pain and the challenges they face every day. Our focus group on the treatment and management of pain, delivered by Gerry Hughes, Senior Pharmacist SJH, tied in with John’s talk. João Joaquim presented on the goals and mission of the European Association of Pharmacy Technicians and included a focus on the mobility of Pharmacy Technicians in the European Union. Karen Delaney, nurse specialist

in Dermatology, from Tallaght Hospital presented a focus group on common skin conditions and the treatments available. The third focus group on writing effectively was delivered by Carol O Brady, Medicines Information Manager, Tallaght Hospital. This is becoming an important skill as all pharmacy staff are involved in writing SOPs, Memorandums and general correspondence on a daily basis. The winner of the poster competition was Claire O Rourke, Mullingar Regional Hospital with her poster “Expansion of the Role of the Pharmacy Technician at Mullingar Regional Hospital. “An audit on inhaler dispensing to A&E and admissions wards and potential cost savings in SVUH” by

In October we held a mid-year education meeting on ‘Therapeutic Options for the Management of Hyperglycaemia’. This meeting was held in the Crowne Plaza, Santry. This meeting was sponsored by Sanofi, in conjunction with Uniphar and was well attended. We have produced three newsletters this year, the content of which includes an article written by Pharmacy Technicians from hospitals around Ireland on their department. Our annual conference is taking place on the April 1th 2017 in Crowne Plaza, Santry. It is the aim of the association to have an even bigger and better conference as we are celebrating our 20th anniversary. Planning is well under way. We had an increase of 10% in our membership in 2016. We would hope to increase the membership again in 2017 by promoting the work of the NAHPT using social media, networking and having representatives at conferences and meetings. We are revamping our website and intend to launch it in January 2017. Laura Lyons, Senior Hospital Pharmacy Technician, Mater Misericordiae University Hospital.


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18 Review: Medical Council

Leadership in Healthcare Professor Freddie Wood, President, Irish Medical Council

We all hear a great deal of debate about healthcare today – issues like hospital hygiene, waiting lists, high-profile failings of care, access to new drugs and technologies and while these matters need to be addressed and are of course, of fundamental importance, studies consistently show that from a patient’s perspective it is the relationship which they establish with an individual healthcare professional that is central to their experience of care. Recent research undertaken by the Medical Council found that doctors benefit from high levels of public trust and this is a very privileged position for the profession to be in, one which must be carefully safeguarded. Leadership, which is a topic that we as a Council return to again and again in our work is a fundamental facet of good patient care. In healthcare, good leadership is more than just important—it is absolutely critical. Like trust, leadership is a term that can be defined in a multitude of ways, but regardless of what you consider to be your own leadership style, the reality is that you cannot decide yourself that you are a leader. That position is earned once a person or people decide to look to you for leadership. One very important aspect of the Council’s work is to support the profession in fully understanding what leadership is and how this leadership can be demonstrated. It is only in recent years that it's been understood that leadership needs to be taught, especially standards of leadership.

Professional Top100 - 2016 • HPN

Leadership, which is a topic that we as a Council return to again and again in our work is a fundamental facet of good patient care. In healthcare, good leadership is more than just important—it is absolutely critical. Often, when we hear about medical failures the blame is firmly laid at the door of “the system.” However, in recent years we have seen through the re-occurrence of adverse events, that the system can often be plagued with mismanagement and a lack of leadership and communication. My colleague on the Council Margaret Murphy strongly makes the point that systems are people. Leaders must insist on transparency and open disclosure in relation to errors, serious incidents, and problems and regard mistakes as opportunities for learning. A culture of ‘speaking out’ needs to be fostered and doctors need to act without delay in order to begin to rectify a mistake or problem that has arisen. I cannot stress how important teamwork is in leadership; it is not the system that fails, it is the teamwork that fails. We as more senior doctors or leaders must ensure that the staff ‘voice’ is encouraged, heard and respected across the organisation. We must create an environment in which our colleagues are not afraid to speak up and we must not intimidate them. The common purpose of a team is much more likely to be

achieved when all who are working in that environment are informed and know exactly what the aim is. Being a good doctor means a lot more than simply being a good clinician. Effective leaders in health services need to continually stress that safe, high quality, compassionate care is of the utmost concern. We saw from our five-year review of complaints to the Medical Council that common factors for causes of complaints were a lack of communication and compassionate behaviour between doctors and their patients. This shows that communication and compassion are not simply perceived as a ‘bonus’ by patients, but an absolute inherent part of the patient-doctor relationship. Doctors need to offer compassionate, supportive, empathic, fair and respectful care to their patients. Leaders must keep their professionals skills up-to-date and promote continuous development of knowledge, skills and abilities to their staff or colleagues in order to improve quality of patient care the patient experiences. For all of us, it’s never good enough to stand still; to reach our

maximum potential we need to continually respond to the evolving environments in which we are in. We need to build on our training and look at our existing skills and abilities and explore new ways of developing different aspects of our professional identity. Continuing professional development is the process of tracking and documenting the skills, knowledge and experience that you gain both formally and informally as you work, beyond the days of training. Since 2011 all doctors who are registered in the general, specialist and supervised division of the Medical Council’s register have had a legal requirement to maintain professional competence by enrolling in a professional competence scheme with a recognised postgraduate training body. As the regulator we have a statutory responsibility to ensure that all doctors are carrying out their duty with the primary aim of ensuring patients are safeguarded to the highest possible degree. One of the principle ways in which we can demonstrate leadership is through the reflection on day-to-day practice. I firmly believe that we need to be take leadership in this area and be accountable for our own actions and adhere to best practice through self-monitoring and objective assessment in the form of data collection, measurement and evaluation. Clinical audit represents one of the most powerful tools at our disposal to enable doctors to maintain their professional competence and to improve the quality of patient care. We need to ensure that our teams regularly take time out from their work to review their performance and look at how it can be improved. The key component of clinical audit is that performance is reviewed to ensure that what should be done is being done. As John F. Kennedy once said “Leadership and Learning are Indispensable to each other”. And I believe this to be entirely true as leadership is not something we are born with, it is something that is acquired over time and is a fundamental aspect of patient care. Professor Freddie Wood, President of the Irish Medical Council.


20 Review: IPHA

Building on the Medicines Platform Mr Oliver O'Connor, CEO, IPHA

Department of Health and the Oireachtas Health Committee to set adoption of new medicines as a performance indicator alongside financial performance issues.

2016 has been a very busy and challenging year for the Irish Pharmaceutical Healthcare Association. CEO Mr Oliver O’Connor outlines they key issues addressed and looks to the organisation’s agenda for 2017. An Agreement that works for patients The clearest reflection of this was in July. After intensive negotiations lasting many months, IPHA concluded a new four year Framework Agreement with the Government for an economic and secure supply of medicines to patients. The Agreement is the latest in a series of formal pricing and supply arrangements between the research based pharmaceutical industry, represented by IPHA, and the Government. These arrangements have for many years provided a workable and practical structure through which the Government has been able to provide innovative medicines to patients. They are built on two essential elements: a pricing framework and a process for approval of reimbursement of new medicines. IPHA at all times was keen to ensure that the best possible arrangements were put in place which would see patients having access to life-saving and lifeenhancing new medicines. The Agreement contains a clear HSE process and sustainable pricing structure to allow new medicines to be made available quickly to patients in Ireland. For the four year period to 2020, the Agreement facilitates stability in the supply of medicines to patients and for the treating clinicians. The new Agreement will see Professional Top100 - 2016 • HPN

savings of ¤785 million over four years, as compared with no agreement. This is an average of nearly ¤200 million a year, a very considerable amount by any standards. The ex-factory prices for our medicines in Ireland are now set at an average of fourteen other EU member states. Medicines prices are set at a level that is appropriate to Ireland’s economic level in Europe. A notable aspect of the Agreement is the fact that for the first time prices will be 'realigned' annually to this average. On the basis that this average price of a medicines will fall continuously, prices in Ireland will fall too. Realignments are 'downward only'. Having commenced on 1st August this year, reductions will be applied from 1st July for the subsequent years of the Agreement. The new Agreement is good news for patients, for their doctors, dentists and prescribing nurses, for the health service and taxpayers. Already, price reductions on hundreds of medicines have occurred and savings are being made for the HSE budget. Budget headroom has been created for the HSE. It is essential that new medicines are made available to patients with this funding. Clinicians and their patients rightly expect that the Agreement will work to deliver fast access to new medicines. An essential benchmark for the success of the Agreement will be the number of new medicines and the speed of adoption. The savings committed to will no doubt be scrutinised by commentators and the Oireachtas. Access to new medicines deserves equal scrutiny. IPHA will be encouraging the HSE, the

Making the Agreement work for patients as intended as a top priority for 2017. We also intend to look to the future through an exploration of how outcomes based models of healthcare financing could be applied to Ireland. A lot of work has been done on this by the European Federation of Pharmaceutical Industries and Associations (EFPIA). We are keen to explore how elements of such a model could be adopted in Ireland over time, with the right data and design. Better transparency 2016 saw a major step forward in transparency by IPHA member companies. Following a long period of stakeholder engagement and awareness raising, payments made by companies to healthcare professionals and healthcare organisations were published in a central report on a dedicated website www.transferofvalue.ie. This commenced on 30th June and was part of a European wide EFPIA initiative. It is important to note that this is a voluntary initiative by industry and was not mandated by any legislation. Collaborations between industry and the healthcare community are vital in the development of innovative medicines. Medicines have a very significant impact on the quality and length of peoples’ lives. 40%-58% of the very significant increased life expectancy observed in 50 countries between 1986 and 200 was due to innovative medicines. Minister for Health Simon Harris, T.D. acknowledged this himself recently in response to a parliamentary question when he said: “it is important … to appreciate that engagements between clinicians and the pharmaceutical industry is a necessity and is central to excellence in clinical care as well as research”.

In 2017 we will continue to work with member companies and stakeholders with a view maximising consent levels to disclosure by healthcare professionals. It is our aim to attain a consent level of 100%. IPHA President, Mary Dickens said in her first IPHA Conference speech on November 17th, “100% public disclosure is in the public interest." This would give maximum assurance to the public that the interaction between the industry and healthcare professionals is for patients' interest and the advancement of scientific knowledge. Getting to grips with falsified medicines In 2017 IPHA will continue to play a leading role in ensuring that by the deadline of February 2019, patients in Ireland are assured every time they are dispensed a medicine that it is fully authentic. Over 100 million times a year in Ireland, medicines will be checked to ensure their authenticity by computer scanning in less than a third of a second. Together with industry stakeholders - pharmacists, in both hospitals and community, wholesalers, parallel importers and generics suppliers - we are building this system in Ireland and across Europe. This is being carried out as the industry's responsibility under the European Falsified Medicines Directive. It is a mandate we take very seriously as it will provide even higher assurance to patients about their medicines. Putting the industry at the heart of “Healthy Ireland” Member companies of the Consumer Healthcare Division of IPHA are committed to the promotion and development of patient empowerment through 'self-care' for minor illnesses. The concept of people taking ownership for their own health and well-being is now firmly established as a policy priority for Government through the “Healthy Ireland” Initiative. We will be playing a far more central role in supporting it in 2017 and will explore with Minister for Health Promotion, Marcella Corcoran Kennedy how to support her agenda for better health and self-care. One innovation industry message The National Institute for Bioprocessing Research and Training (NIBRT), IPHA and


21 We look forward therefore to 2017 as a year to build on the platforms we have established in 2016 on access to medicines, pricing and supply, transparency, authentication of medicines and the promotion of one innovation industry based here in Ireland. BioPharmaChem Ireland jointly hosted the inaugural BioPharma Ambition Convention in September. For the first time ever, the industry in Ireland spoke as one voice in an international showcase of the

biopharmaceutical industry in Ireland. An array of global thought leaders from the world of academia and regulation, joined with senior company innovators to explore currents trends and map out the exciting frontiers of the future. A

report of the conference is available at www.biopharmaambition.com. We intend to strengthen and bolster these collaborations between the commercial and manufacturing side of our industry and have already commenced planning for a follow up BioPharma Ambition event. Relocation of European Medicines Agency – a big opportunity for Ireland The Irish Government is making a strong pitch for the European Medicines Agency (EMA) to be relocated to Dublin from London following the UK’s Brexit vote.

Ireland has a strong case, but is facing stiff competition from other EU states to land an institution which employs over 900 people. IPHA intends to play a pro-active role in supporting Government efforts for what is a big opportunity for Ireland. We look forward therefore to 2017 as a year to build on the platforms we have established in 2016 on access to medicines, pricing and supply, transparency, authentication of medicines and the promotion of one innovation industry based here in Ireland.

Review: HPRA

HPRA on New Medical Legislation level, which means they can be marketed across the EU.

Lorraine Nolan, President, HPRA

The Health Products Regulatory Authority (HPRA) is the government agency responsible for the regulation of health products. The health products area is vast and includes medicines as well as all medical devices and equipment used for medical purposes. Health products can be life-saving and can also improve the health and the quality of our lives. At the HPRA, it is our role to ensure that the health products used by those working in our health service, and by patients directly, are as safe as possible and do what they are intended to do. A primary function of the HPRA is to grant marketing authorisations for medicines following a review of their safety, quality and effectiveness. The decision to grant an authorisation is based on a review of applications submitted by pharmaceutical companies and involves an evaluation of the benefit-risk profile. Some medicines are authorised nationally with others at a European

Those working in our health system play a critical role in pharmacovigilance. When a drug is first marketed, based on clinical trial data much may be known about its efficacy but its safety profile continues to be monitored. Post-marketing surveillance is essential to help in the identification of drug safety problems which may not have been detected during pre-marketing evaluation. We ask that healthcare professionals contact us to report suspected adverse reactions observed through their work. While all reporting is important, reporting of suspected reactions to newly authorised products, serious reactions to established products, products undergoing additional monitoring and suspected reactions to vaccines or medicines used in pregnancy are crucial. Medical devices in the hospital setting

encourages those who have experienced a safety issue with a medical device to report that issue to us. Issues or concerns about any medical equipment can be quickly submitted through our online reporting system on www.hpra.ie. Suspected adverse reactions to medicines can be reported in exactly the same way. New medical devices legislation The regulation of the health product industries and their products need to keep pace with the level of on-going innovation within these sectors. This is key to ensuring that patients, regardless of progress and innovation, have access to products and technologies that are effective, safe and fit-for-purpose. We have seen some issues come to the fore with medical devices in the past decade and this has resulted in an emphasis on revising the current regulations to further protect patients.

Those working in our health system will be well aware of how new and innovative medical device technologies have revolutionised health care and provided a better quality of life for many thousands of people. At the HPRA, it is our role through our vigilance activities to monitor the safety of all medical devices in use on the Irish market.

The HPRA has spent a number of years working at a European level to improve the legislation around the regulation of medical devices. The new legislation, which will come into effect from 2017, will ensure improved oversight of the product approval process, increased market surveillance, clearer product requirements and improved information, transparency and governance.

Regardless of the type of medical device being used, whether it is a plaster or a coronary pacemaker, there is always the potential for a safety or quality issue to arise and those working in our hospitals will often be best placed to observe such issues. The HPRA strongly

This legislation will have a positive impact on the healthcare environment as a whole. For healthcare professionals, they will have the assurance that patients have access to the most innovative products, without compromising on quality and safety standards.

The Future This is an exciting time for the HPRA as an organisation. As well as preparing for the introduction of new regulations in respect of medical devices, clinical trials and veterinary medicines, at the start of the year we also launched our strategic plan for 2016 to 2020. The strategic plan includes a clear focus on: • Better informed users: Those working in our hospitals and other healthcare settings, general practitioners, pharmacists, and the public need access to clear, readily available, high-quality information on which to base their health decisions. • Access to health products: The HPRA is committed to working with all stakeholders to enhance access to health products. This includes measures to reduce and manage medicine shortages as well as protecting the integrity of the supply chain to avoid illegal products reaching patients. • Supporting innovation: We will strengthen our capabilities in providing regulatory assistance to innovators and others involved in developing new products. The actions and activities identified in our strategic plan provide a clear roadmap for the future focus and development of the HPRA. It clearly outlines the role we must play in ensuring that the health products we regulate are as safe and beneficial as possible for the health professionals and patients who use them. Lorraine Nolan, President, Health Products Regulatory Authority. HPN • Professional Top100 - 2016


22 Review: Cancer Trials

Cancer trials needs to be mainstreamed not seen as a last resort Eibhlin Mulroe CEO Cancer Trials Ireland

HSE would be calculated at ¤10.7 million in that year alone. The challenge for the year ahead is to build on this very positive track record of commitment and the expertise of clinicians and researchers around the country in opening and running valuable cancer trials. Denmark’s population size is similar to Ireland’s and its achievements as a world leader in clinical trials illustrate the potential for Ireland.

In 2012, there were 14.1 million new cancer cases and 8.2 million cancer-related deaths worldwide. The World Health Organisation projects that by 2035 the world could see 24 million new cancer cases and 14.5 million cancerrelated deaths a year. While significant progress has been made in the fight against cancer, these projections highlight how inadequate current methods of preventing, diagnosing and treating cancer are and the extent of the challenge ahead. Incidences of cancer in Ireland reflect what is happening globally. The number of new cases of invasive cancer cases (including non-melanoma skin cancer) is expected to increase by between 86% and 125% for females and by between 126% and 133% for males between 2010 and 2040. In Ireland the Department of Health's 2015-2017 Statement of Strategy notes that the incidences of cancer are projected to double by 2040. It states that “a key task in the coming years will be to work to prevent cancer occurring in the first place as far as possible and to tackle cancer early when it does occur”. In the global search for better ways to diagnose and treat cancer, rigorous local, national and global cancer trials are pivotal. Without them novel diagnostics and treatments cannot be identified, proven or made available to patients. Cancer Trials Ireland and the associated research teams and their clinical leaders around the

Professional Top100 - 2016 • HPN

country are contributing positively to finding the answers to cancer. Based on its 20 year history of successfully opening and running cancer trials, it believes that Ireland has the opportunity and capability to take greater advantage of the opportunities conducting cancer trials in Ireland affords patients and the wider economy. At a broad level conducting cancer trials in Ireland provides many benefits for patients and economic benefits for the wider economy. Cancer Trials Ireland’s trials provide patients with access to treatments that they would not be able to access if they were not taking part in a trial. Due to Ireland’s relatively small population size, opening cancer trials in Ireland in partnership pharmaceutical companies and international research groups, is sometimes the only way that a treatment, readily available in other parts of Europe and the USA, can be made available to Irish patients. Evidence shows that cancer trials have given participants many extra quality-adjusted life years (QALYs). Based on a small sample of case studies of trials (TAILORx, Monotherapy in Untreated Melanoma, BCIRG 006, PALOMA-1) it is estimated that the health benefits of each trial (considering only the Irish patients who participated in the trials, for the period of follow-up), ranges from 6 to 16 QALYs per trial. The equivalent economic benefits of these QALYs range from ¤0.28 million to ¤0.72 million per trial. Subsequent benefits, when therapies become available to the generality of patients, would be a multiple of these values.

In 2016 Cancer Trials Ireland will receive from the Exchequer just over ¤3 million to fund resources in participating hospitals to run trials. It will leverage this investment and generate an additional ¤4.5 million from other sources such as the pharmaceutical industry, international research groups and granting agencies. As a direct result of its work, it will add a total of ¤16.5 million to Irish GDP per annum, and generate tax revenues for the Exchequer of ¤5.8 million per annum. For every ¤1 the Exchequer invests in cancer trials it will save more than ¤2 in cancer treatment costs. Participating hospital-based cancer trials research units have confirmed that the grants they receive enable them to secure funding from non-Exchequer sources. One found that for every ¤1 in grant funding they received, it generated a further ¤3 in income from industry for trials. Conservatively, Cancer Trials Ireland saves the HSE in the region of ¤6.5 million annually in cancer drugs costs. This excludes the costs of experimental drugs, avoided treatment costs (as in the case of the Oncotype DX test), and the benefits of improved health and longer lives for patients, leading to lower future healthcare costs. By this metric alone, for every ¤1 the Exchequer invests in cancer trials it will save more than ¤2 in cancer treatment costs. If the costs associated with monitoring and tests are added in, the impact would be greater. By applying the findings of a UK study to the number of people on an open trail during 2015, the savings to the

One of the keys to following in Denmark’s footsteps is a national health policy decision to mainstream cancer trials as a cancer treatment option and their inclusion in Ireland’s strategy to further develop its Life Science industry. Cancer Trials should be integrated into the National Cancer Control Programme at a national policy level and promoted to all clinicians as a mainstream treatment option. Consideration of a cancer trial as an option should not be seen as a last resort or reliant on a patient’s treating clinician’s awareness of available cancer trials. In addition, the target for the number of people participating in cancer drugs trials should be 5%, up from the current participation rate of 3%. The opening of more cancer trials in Ireland by pharmaceutical companies and international collaborative groups should be an objective integral to Ireland’s strategy to further develop its Life Science industry. Both strands of this proposed policy are interdependent. If, as part of Ireland’s national health policy, cancer trials are treated as an integral part of the available cancer treatment modalities, more patients will be available to participate in trials. It will then be possible to open more trials and provide more patients with access to new promising treatments. It will be possible develop further our expertise in this area and attract more investment from pharmaceutical companies and international collaborative groups. If we can attract this investment we can open more trials, and the cycle repeats itself. Eibhlin Muloe is the CEO of Cancer Trials Ireland.


NOW AVAILABLE

In patients with advanced melanoma

KEYTRUDA:

ANTI–PD-1 EFFICACY

FOR EXTENDED SURVIVAL1 68% estimated 1-year overall survival rate with KEYTRUDA 10 mg/kg Q3W vs 58% with ipilimumab (HR=0.69; 95% CI, 0.52-0.90; P=0.00358).1* KEYTRUDA as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.2 Before prescribing please read the Summary of Product Characteristics for KEYTRUDA.

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SPC for how to report adverse reactions. ABRIDGED PRODUCT INFORMATION Refer to Summary of Product Characteristics before prescribing. PRESENTATION One vial of powder containing 50 mg of pembrolizumab. INDICATIONS KEYTRUDA as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. DOSAGE AND ADMINISTRATION See SmPC for full details. Treatment must be initiated and supervised by specialist physicians experienced in the treatment of cancer. The recommended dose is 2 mg/kg administered intravenously over 30 minutes every 3 weeks. Treat patients until disease progression or unacceptable toxicity. Atypical responses (i.e., an initial transient increase in tumour size or small new lesions within the first few months followed by tumour shrinkage) have been observed. Recommended to continue treatment for clinically stable patients with initial evidence of disease progression until disease progression is confirmed. KEYTRUDA should be permanently discontinued (a) For Grade 4 toxicity except for endocrinopathies that are controlled with replacement hormones; (b) If corticosteroid dosing cannot be reduced to ≤10 mg prednisone or equivalent per day within 12 weeks; (c) If a treatment-related toxicity does not resolve to Grade 0-1 within 12 weeks after last dose of KEYTRUDA; (d) If any event occurs a second time at Grade ≥ 3 severity. Patients must be given the Patient Alert Card and be informed about the risks of KEYTRUDA. Special populations Elderly: No overall differences in safety or efficacy reported. No dose adjustment necessary. Renal impairment: No dose adjustment needed for mild or moderate renal impairment. No studies in severe renal impairment. Hepatic impairment: No dose adjustment needed for mild hepatic impairment. No studies in moderate or severe hepatic impairment. Ocular melanoma: Limited safety and efficacy data exist. Paediatric population: Safety and efficacy in children below 18 years of age not established. CONTRAINDICATIONS Hypersensitivity to the active substance or to any excipients. PRECAUTIONS AND WARNINGS Immune-related adverse reactions Most immune related adverse reactions occurring during treatment with pembrolizumab were reversible and managed with interruptions of pembrolizumab, administration of corticosteroids and/or supportive care. Immune related adverse reactions have also occurred after the last dose of pembrolizumab. See SmPC for full details. Immune-related pneumonitis: Monitor for pneumonitis. Suspected pneumonitis should be confirmed with radiographic imaging and other causes excluded. Corticosteroids should be administered for Grade ≥ 2 events; pembrolizumab should be withheld for Grade 2 pneumonitis, and permanently discontinued for Grade 3, Grade 4 or recurrent Grade 2 pneumonitis. Immune-related colitis: Monitor for colitis and exclude other causes. Corticosteroids should be administered for Grade ≥ 2 events; pembrolizumab should be withheld for Grade 2 or Grade 3 colitis, and permanently discontinued for Grade 4 colitis. Consider the potential risk of gastrointestinal perforation. Immune-related hepatitis: Monitor for changes in liver function and symptoms of hepatitis and exclude other causes. Corticosteroids should be administered and, based on severity of liver enzyme elevations, pembrolizumab should be withheld or discontinued. Immune-related nephritis: Monitor for changes in renal function and exclude other causes of renal dysfunction. Corticosteroids should be administered for Grade ≥ 2 events and, based on severity of creatinine elevations, pembrolizumab should be withheld for Grade 2, and permanently discontinued for Grade 3 or Grade 4 nephritis. Immune-related endocrinopathies: For patients with Grade 3 or Grade 4 endocrinopathy that improved to Grade 2 or lower and are controlled with hormone replacement, if indicated, consider continuation of pembrolizumab after corticosteroid taper, if needed. Otherwise discontinue treatment. Long term hormone replacement therapy may be necessary in cases of immune related endocrinopathies. Monitor for hypophysitis (including hypopituitarism and secondary adrenal insufficiency). Exclude other causes. Administer corticosteroids to treat secondary adrenal insufficiency and other hormone replacement as clinically indicated. Withhold pembrolizumab for symptomatic hypophysitis until the event is controlled with hormone replacement. Consider continuation of pembrolizumab, after corticosteroid taper, if needed. Monitor pituitary function and hormone levels. Monitor for hyperglycaemia and/or diabetes. Withhold pembrolizumab in cases of Grade 3 hyperglycaemia until metabolic control is achieved. Monitor for changes in thyroid function. Manage hypothyroidism with replacement therapy without treatment interruption and without corticosteroids. Manage hyperthyroidism symptomatically. Withhold pembrolizumab for Grade ≥ 3 hyperthyroidism until recovery to Grade ≤1. For Grade 3 or 4 hyperthyroidism that improved to Grade 2 or lower, consider continuation of pembrolizumab, after corticosteroid taper, if needed Other clinically significant immune-related adverse reactions: uveitis, arthritis,

myositis, pancreatitis, severe skin reactions, Guillain-Barré syndrome, myasthenic syndrome, optic neuritis, rhabdomyolysis, haemolytic anaemia, and partial seizures arising in a patient with inflammatory foci in brain parenchyma. Based on the severity of the adverse reaction, pembrolizumab should be withheld and corticosteroids administered. Pembrolizumab may be restarted within 12 weeks after last dose if the adverse reaction remains at Grade ≤ 1 and corticosteroid dose has been reduced to ≤ 10 mg prednisone or equivalent per day. Pembrolizumab must be permanently discontinued for any Grade 3 immune related adverse reaction that recurs and for any Grade 4 immune related adverse reaction toxicity. Infusion-related reactions: For severe infusion reactions, stop infusion and permanently discontinue pembrolizumab. With mild or moderate infusion reactions, infusion may continue with close monitoring. Premedication with antipyretic and antihistamine may be considered. Overdose: There is no information on overdose with pembrolizumab. In case of overdose, monitor closely for signs or symptoms of adverse reactions and treat appropriately. INTERACTIONS No formal pharmacokinetic drug interaction studies have been conducted with pembrolizumab. No metabolic drug drug interactions are expected. The use of systemic corticosteroids or immunosuppressants before starting pembrolizumab should be avoided because of their potential interference with the pharmacodynamic activity and efficacy of pembrolizumab. However, systemic corticosteroids or other immunosuppressants can be used after starting pembrolizumab to treat immune related adverse reactions. PREGNANCY AND LACTATION Pregnancy No data on use in pregnant women. Do not use during pregnancy unless the clinical condition of the woman requires treatment with pembrolizumab. Women of childbearing potential should use effective contraception during treatment with pembrolizumab and for at least 4 months after the last dose of pembrolizumab. Breast-feeding It is unknown whether pembrolizumab is secreted in human milk. A risk to newborns/ infants cannot be excluded. A decision should be made whether to discontinue breast feeding or to discontinue pembrolizumab, taking into account the benefit of breast feeding for the child and the benefit of pembrolizumab therapy for the woman. Fertility No clinical data available. SIDE EFFECTS Refer to SmPC for complete information on side effects. Pembrolizumab is most commonly associated with immune-related adverse reactions. Most of these reactions resolved with appropriate medical treatment or withdrawal of pembrolizumab. The most serious adverse reactions were immune-and infusion-related adverse reactions. Very Common: diarrhoea, nausea, rash, pruritus, vitiligo, arthralgia, fatigue. Common: anaemia, hyperthyroidism, hypothyroidism, decreased appetite, insomnia, headache, dysgeusia, neuropathy peripheral, dizziness, dry eye, pneumonitis, dyspnea, cough, colitis, vomiting, abdominal pain, constipation, dry mouth, hepatitis, severe skin reactions, eczema, erythema, dry skin, hair colour changes, myositis, alopecia, musculoskeletal pain, pain in extremity, arthritis, oedema, asthenia, pyrexia, influenza like illness, chills, AST and ALT increases, blood bilirubin increased, increase in blood alkaline phosphatase, infusion related reaction. PACKAGE QUANTITIES 1 x 15 mL Type I glass vial Legal Category: POM. Marketing Authorisation numbers EU/1/15/1024/001 Marketing Authorisation holder Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU United Kingdom. Date of revision: April 2016. © Merck Sharp and Dohme Ireland (Human Health) Limited 2015. All rights reserved. Further information is available on request from: MSD, Red Oak North, South County Business Park, Leopardstown, Dublin 18 or from www.medicines.ie. Date of preparation: July 2016. Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie Adverse events should also be reported to MSD (Tel: 01-299 8700) References 1. Robert C, Schachter J, Long GV, et al. Pembrolizumab versus ipilimumab in advanced melanoma. N Engl J Med. 2015;372(26):2521–2532. 2. KEYTRUDA Summary of Product Characteristics. * The recommended dose of KEYTRUDA is 2 mg/kg intravenously over 30 minutes every three weeks. Red Oak North, South County Business Park, Leopardstown, Dublin D18 X5K7 Ireland

ONCO-1189033-0000

KEYTRUDA® ▼ (pembrolizumab)


HPN Awards: Excellence in Patient Safety

Implementing Standardised Practice in Paediatric Critical Care Moninne Howlett, Chief Pharmacist, Our Lady's Children's Hospital

Critically ill paediatric patients are a vulnerable cohort of patients at high risk of medication error. The risks in preparing paediatric and neonatal infusions have been specifically addressed over the last 15 years. Moninne Howlett has been working as a Senior Pharmacist in Our Lady’s Children’s Hospital Crumlin (OLCHC) since 2002. In 2010 she took up her current role as pharmacist on the Paediatric Intensive Care Unit (PICU). In 2011 she became involved in the configuration of a paediatric specific electronic drug file to facilitate electronic prescribing on the Clinical Information Management System in PICU. She is also involved in the on-going development of an electronic drug file used in the delivery of intravenous infusions using smartpump technology. She is currently undertaking a 2 year study to investigate the effect these two systems have had on medication errors since their implementation in PICU. Recommendations include the replacement of traditional individualised weight-based infusions with standard concentration infusions (SCIs) and the use of smart-pump technology. Wide scale implementation of these have been advocated by the Joint Commission on Accreditation of Healthcare Organisations (JCAHO) and international safety agencies. Despite this uptake has been slow, with implementation rates

Professional Top100 - 2016 • HPN

in Europe falling far below those in the US. The creation of a smart-pump drug library and Pharmacy input have been identified as limiting, yet crucial factors to enable implementation. Development and Implementation In 2012, Our Lady’s Children’s Hospital Crumlin developed and implemented a smart-pump drug library of paediatric SCIs into their paediatric intensive care unit, operating theatres and cardiac ward. In the absence of guidelines or standards on how to implement the recommendations the following process was undertaken: • A list of medications delivered by infusion in the PICU setting was developed. • The most appropriate standardised concentrations over a number of weight bands were identified.

• Information and training sessions were run for approximately 175 staff prior to implementation. A few months later, a clinical management content system (CIMS) was introduced into the PICU. A further safety initiative was to integrate the smart-pumps with the CIMS. A range of ‘standard orders’ or prefilled electronic prescriptions were created for each SCI. The system was set up to only allow the prescribing of orders appropriate for the patient based on their age and weight. Furthermore, the pumps were connected to the CIMS using a uni-directional interface facilitating auto-transfer of real-time data. This level of integration is yet to be attained in the majority of paediatric institutions across Europe. In late 2014, the Irish Paediatric Acute Transport Services (IPATS) was commissioned and was to be run out of the PICUs in both OLCHC and Temple Street Children’s University Hospital (TSCUH). With the current resource restraints in the Irish health service, and critically ill children’s safety being paramount, a decision was made to standardise practices and align all sites with best practice recommendations. Extending Use Agreement was reached from the respective departments of pharmacy and paediatric intensive care to extend the use

Figure 1: Image of Smart Pumps

• Custom made calculators were created to facilitate modelling of various concentrations, balancing excessive infusion volumes with titratability at lower dose ranges. The minimum number of concentrations was included to mitigate against selection errors. • Supporting documentation and guidelines were devised.

Figure 1: Smart Pumps

Figure 2: Screen Shots of Smart Pump Library

of the OLCHC drug library to both TSCUH and IPATS. • A cross-site multidisciplinary working group was formed. • A master drug library of paediatric SCIs drug library was devised • Legally binding agreements were drawn up between OLCHC and recipient sites. • All staff were trained • Implementation occurred in late 2015/early 2016. A post-implementation user survey carried out in OLCHC in 2012 indicated that staff were overwhelmingly positive about the change to SCIs finding it much easier to prescribe, prepare and administer drug infusions. Results from a 3 year study in OLCHC measuring the impact of the new technology indicate significant reductions in infusionrelated prescribing errors. Prior to the introduction of electronic orders on CIMS, a 60% reduction in infusion error rates was reported by the replacement of weightbased infusions with standard concentration infusions. A further reduction of 36% is reported when the prescribing of the infusions was transferred from a paperbased system to electronic orders. Data from TSCUH indicates that the number of reported infusion related medication incidents has fallen by 50% following dissemination of the system to


Figure 2: Screen Shots of Smart Pump Library

Figure 2: Screen Shots of Smart Pump Library

to support a collaborative project to standardise paediatric infusions across Europe.

that site. As part of the master drug file build, a national audit of current infusion practices across neonatal intensive care units (NICUs) was undertaken by the lead pharmacist in OLCHC. Considerable diversity was identified. Adapting Proposals Hence in 2014, she and the lead intensivist brought a proposal to the Neonatal Advisory Group (NAG) of the National Clinical Programme for Paediatrics and Neonatology. This initiative, to develop a subsidiary library for use in neonatal units nationally was endorsed by the NAG, including the National Neonatal Transport Programme (NNTP) and the national Maternity and Neonatal Clinical Management System (MN-CMS) project team. A multidisciplinary working group was established with representation from a number of the larger maternity hospitals. A national neonatal SCI library was subsequently developed and has recently been signed off. It is currently being piloted in two Dublin maternity hospitals. It is envisaged that implementation in the other neonatal units will follow in a phased manner. Attempts are currently been made to acquire HSE funding to support this.

stabilisation prior to transport to a PICU. One of the drivers for this has been the number of times regional centres have contacted OLCHC for guidance in stabilising sick children. A draft library has been developed in OLCHC for this purpose, with one or two adult sites expressing interest in acting as pilot sites for this project. Figure Image of Pumps in Action The3:OLCHC lead pharmacist

Figure 3: Pumps in Action

“When you work as hard as we do behind the scenes, in a very resource limited environment, it is fantastic to get the opportunity to work collaboratively and therefore maximise our use of resources for the benefit of the children. “We feel very honoured to be recognised for our work with this Award which I am happy to accept on behalf of the entire team as it is truly a multidisciplinary effort.” In Ireland, current practices for preparing high-risk infusions is overwhelmingly reliant on nurses preparing syringes at the bedside. This is known to be an error prone, resource heavy, inefficient and inaccurate process which frequently involves the manipulation and dilution of adult preparations. Wide scale standardisation is essential to enable moves towards pre-prepared paediatric infusions, prepared either commercially or by a HSE-managed centralised intravenous additive service (CIVAS). This project has made significant progress towards achieving this goal.

Further plans are to extend the use of the paediatric SCI library to paediatric patients cared for in adult intensive care units or regional hospitals, or during

Awards Hospital Professional

and intensivist for this project now sit on the expert advisory group of a paediatric patient safety collaboration looking to standardise paediatric infusions across the UK. They have also contributed to a recent EU Cost Action submission for EU funding

“This project involved the clever use of technology to improve patient safety for a vulnerable group of patients that are very ill. It was a collaborative piece of work carried out within our own hospital and with other paediatric hospitals and the maternity hospitals,” explains Moninne.

2017

Lead Pharmacist at Our Lady’s Children’s Hospital & Drug File Design Lead Moninne Howlett and team won the Excellence in Patient Safety Award at the 2016 Hospital Professional Awards.

Hospital Professional Awards 2017, Saturday September 16th, 2017, Clayton Hotel (Burlington) Dublin HPN • Professional Top100 - 2016


HPN Awards: Consultant-Led Team

Ireland leading the way in lung transplantation The Mater Misericordiae University Hospital Transplant Team- Celebrating 10 years of Lung Transplantation

The Mater Misericordiae University Hospital Transplant Team- Celebrating 10 years of Lung Transplantation

We are one of the most dedicated teams in the hospital sector but it is a real privilege to be able to work within the field of transplantation in Ireland. The survival for lung transplants performed in Ireland is among the best in the world. The success here is largely down to attention to detail and micromanaging each issue. “In transplant, picking up and acting on small issues can result in significant improvements to quality of life and improving outcomes,” says Dr Oisin O’Connell, Consultant Medical Lead at the Mater Misericordiae University Hospital (MMUH) and one of the hospital’s Lung Transplant team leads. The Lung transplant team in the Mater Misericordiae University Hospital celebrated a record

Professional Top100 - 2016 • HPN

year in 2015 by conducting a record number of lung transplants, and a number of other “firsts” including the first heart-lung transplant and the first Irish EVLP transplant. The medical team is led by Medical Consultants Dr O’Connell and Professor Jim Egan. The EVLP technique allows more time for the team to assess and manage donated lungs using a machine and therefore gives more patients the chance of receiving the “gift of life”. These advances in the complexity and volume of transplant surgery are only possible with the concerted

teamwork of a highly skilled group of professionals. The team were recently featured on the Late Late Show along-side three patients who benefited from unique lifesaving surgery made possible by the multidisciplinary team. Furthermore, their work in this field led them to be awarded the title of HPN Consultant-Led Team of the Year, at the Hospital Professional Awards 2016. When the Irish lung transplant team was formed by Professor Egan in 2005, it was carefully constructed to include the entire range of professions from medical, surgical and allied health. In this way it was already ahead of best practice internationally where such teams are generally nurse and doctor led, and miss out on the expertise of the allied health team. The team have a focus on the well-being of the patient, and, with so many professionals working in unison all elements of patient care are delivered coherently.

The team are initially involved in the assessment of patients for transplant, working together to ensure that the patients have the best chance of being suitable for transplant, whether it is by physiotherapy rehabilitation, medication optimisation and education, or nutrition management. They ensure that the patient understands exactly what transplant will involve for themselves and their carers. All of this is essential to ensure that the patient can be successfully transplanted. Life on the transplant waiting list can be an emotionally difficult time for patients and every week each patient receives a phone call from the transplant co-ordinators so that the patient can keep the transplant team up to date on their condition and get support required from the team such as additional oxygen, encouragement to continue with pulmonary rehab or advice on medication related side effects. The Mater Misericordiae University Hospital is fortunate


Catherine Boyle, Conor Dalton and Mairead O'Connor

Professor Jim Egan

in having a highly skilled, internationally renowned team of surgeons who have pushed the surgical boundaries in transplant since the programme inception.

exercise. The dietician ensures that nutrition is optimised and that the patient understands the dietary restrictions after transplant.

The team are renowned for their expertise in performing single lung transplants in pulmonary fibrosis; which is an unmet need internationally.

The Medical Social Worker, Speech and Language Therapist and Psychologist are involved where the patient has specific additional needs. The ward nursing staff develop an invaluable relationship with the patients helping them to stick to their rehabilitation goals, monitoring very closely for any problems and helping the other professionals to provide individualised patient care.

Two papers have been published in the BMJ outlining the MMUH protocols and strategies. This success has led to numerous patients being referred for transplant from outside the state. Following transplant, the multidisciplinary team is involved in every aspect of the patient’s care; the Transplant Pharmacist manages medication choice, dosage and medication education. The physiotherapists ensure that the patients are meeting their exercise goals, often creating ingenious contraptions and incentives (such as floor markings listing all the counties in Ireland) to help debilitated patients to

From hospital discharge, the clinical nurse specialists take on the management of the patient’s care and make all the necessary referrals to the team to ensure that the patient can gain the maximum benefit from the gift of life that they received. With so many different professionals, it is crucial that there is open communication between everyone on the team.

When it was first formed, it was made clear to them that this team was different, although the final clinical decision making for complex patients rested with the Consultant, the team were all expected to have an informed opinion on their individual area of expertise and to express it clearly and succinctly so that the best decision could be made for the patient. Dr Oisin O’Connell says, “Even on the occasions where they are overruled, they definitely know that they are heard. The fact that the very best is expected of us and that we are specifically accountable for our actions has had a huge effect on the confidence of every member of the team. Doctors who rotate through the area have remarked that it is a team like no other. The multidisciplinary rounds offer opportunities for new members to integrate and learn, in conjunction with less formal daily debriefs. We are well known for marking the little milestones in team members lives with tea and cake or a night

out. Our ward clerk, Brid never forgets to organise this!” The Transplant Pharmacist Patricia Ging adds, “Our patients are really grateful for the care that they receive; I feel that I might be the only Pharmacist in the hospital where my patients know me by name! Patients are very generous in fundraising for the heart lung transplant unit. This year we were delighted to be able to use some of this money for a patient focussed project and we have been working extremely hard as a team to update the “Mater Transplant Information Book” for patients. This was a massive multidisciplinary undertaking and has involved rewriting the entire document so that it more closely meets the current needs of our patients. We are also proud that we were able to involve a number of transplant patients in the review and editing of the book, they have given us a new insight into their needs at a difficult time for them. “In the current economic climate

HPN • Professional Top100 - 2016


HPN Awards: Consultant-Led Team Transplant Pharmacist Patricia Ging

experience in the transplant day unit and improve outcomes in a resource limited environment. Dr O'Connell is involved in an international research project with several of the other best lung transplant programs in the world to develop novel microarray techniques to improve the diagnosis and management of the subtypes of rejection that can effect patients after transplant. The transplant surgeons are continuously striving to improve surgical techniques and to operate on more complex patients following the success of the ODTI in massively increasing transplant numbers in Ireland over the last few years. Dr O'Connell says, "I am delighted to accept this Award on behalf of the heart and lung transplant team at the Mater Misericoridae University Hospital. It is a pleasure to work with such a dedicated and committed team. It is a real privilege to be able to work within the field of transplantation in Ireland.

we have been proactive in identifying cost savings for the programme. We had a team meeting with the hospital CEO in October 2015 and as a team agreed a package of changes in prescribing aiming to save in excess of ¤100,000. Obviously to change a winning formula of prescribing requires huge team trust, attention to detail and courage. The mark of the team is that they have been able to work together to achieve the savings anticipated while continuing to deliver top class care. “We have also continued to innovate by working with the biochemistry lab to bring voriconazole drug level monitoring in-house, our growing expertise in this area has received international attention. Sarah Winward, a post-transplant nurse specialist

and qualified nurse prescriber, has worked with the pharmacist to devise a novel tacrolimus dose adjustment algorithm. This has made the post-transplant clinic more streamlined and time efficient.” Dr O’Connell says the biggest opportunity for success in transplantation moving forward into the future, will be increasing organ donor awareness and for donor families to understand the importance and huge improvements in quality of life that people can achieve after organ donation. The Organ Donor Transplant Office in Ireland is adopting several of the strategies used by the Spanish model, who are the world leaders internationally in solid organ donor numbers.

Awards Hospital Professional

Professional Top100 - 2016 • HPN

The team are currently working on a number of new innovations

2017

and are undertaking several research projects. Dr Katie O'Brien the post lung transplant psychologist is undertaking research with the RCSI and the Cochrane review board to improve compliance strategies post lung transplant. Ms Ciara Murphy, the transplant SLT is doing research to reduce aspiration events after transplant which are thought to be a significant factor in increasing rejection and pneumonia rates after transplant. Ms Petra Grehan and Ms Irene Byrne the transplant physios are developing novel patient-specific rehabilitation regimes which they have been presenting internationally. Mr Iain Lawlie one the the transplant CNS's is undertaking a "Lean management program" to improve the patient

“Transplants change lives, we have the unique opportunity to not only help our patients to live longer but to keep families and friends together for longer. Transplant changes lives, and it is clear that the Lung transplant team in the Mater give that extra 10% for their patients each and every day to makes the changes required for striving to achieve to be the best. “To win the Consultant-Led Team of the Year Award and to have our work acknowledged in a great honour for the whole team.” The Mater lung transplant programme is a success story of the Irish health service; this is seen from both the increasing numbers of patients being treated as well as the complexity of these patients. To manage this extraordinary growth within current resources has required the innovation, dedication and determination of an extraordinary team. Consultant Medical Leads Dr Oisin O’Connell and Professor Jim Egan led the Mater Team to winning the Consultant-Led Team of the Year Award 2016.

Hospital Professional Awards 2017, Saturday September 16th, 2017, Clayton Hotel (Burlington) Dublin


HPN Awards: Shire Excellence in Child Psychiatry

Playing a pivotal role in Psychiatric care

Back: Carole Boylan, Dr Elizabeth Barrett, Vice-Chair, Bridget Conway, Caroline McGrath, Sara McMahon and Edel McCarra. Front: Anna Delahunt, Marianne O'Reilly, Roisin Gowan, Chair and Lani Smith

Psychiatric professionals and teams play a pivotal role in improving or innovating psychiatric services and care for children and adolescents. The Paediatric Eating Disorder Cross-Hospital Working Group at Our Lady’s Children’s Hospital, Crumlin have gained acclaim for their work in this niche area. Children under 18 years comprise 25% of the population i.e. one million. Overall, 1 in 5 children in Ireland have a mental or behavioural disorder at any one time. International evidence demonstrates that mental illness is

young people’s number one health issue, representing over half their total burden of disease (combining both fatal and nonfatal measures). Three quarters of lifetime cases of mental illnesses emerge by the age of 24 and, across Europe, the overall prevalence of mental disorders in adolescence is in the region of 15 to 20%. Most of these young people will get no treatment. Eating disorders are serious mental illnesses that can represent a major threat to normal development in young people. A 2000 European Commission working paper states: “The prevalence of anorexia

nervosa among adolescents stands at about 1%, and that of bulimia nervosa at 1.5-2% About 20% of early cases of eating disorders become chronic and about 6% will die of their illness. Eating disorders have become more common in adolescents during the past 20 years. Anorexia nervosa among young females increased until the late 1980s, while bulimia is still increasing. About 10 times more females suffer from eating disorders than males.” Elsewhere, Binge Eating Disorder (which often results in considerable weight gain) has been estimated at 4% of the general population whilst

in Ireland, obesity levels increased by 67% between 1990 and 2000. The World Health Organisation stresses that eating disorders must be seen as disorders with lifelong consequences, citing a study of college students that found that 21.6% of females with eating disorders still meet the clinical criteria 10 years later. Roisin Gowan, Senior Dietician recognised the lack of direction for all staff in the acute admission for Paediatric patients with an eating disorder (ED) and in late 2015 contacted multiple disciplines to gather a multidisciplinary approach to developing guidance to the

HPN • Professional Top100 - 2016


HPN Awards: Shire Excellence in Child Psychiatry

This project is innovative in its cross-hospital need for patients to be treated in acute setting. The aim is not to initiate a new service, but use the limited resources we have in our current service to help deliver the best possible approach to patient care and patient safety.

were identified as being ‘at risk’ of developing Bulimia Nervosa. Although the global levels of eating concern among Irish adolescents are comparable to those established internationally, there is a suggestion that Irish adolescents may demonstrate higher levels of bulimic type behaviours and concerns. Table 2: The Department of Health Children estimates that:

treatment of the acutely unwell patient with an eating disorder. There is an inconsistency in the approach to treatment of patients who are admitted to the acute hospital setting. It is estimated that that approximately- 12 admissions in November-December 2015 (OLCHC). Each admission has and emergency department admission, followed by admission to an acute ward with general nursing staff. Dieticians, Psychiatry, Medical team and other professions will all have involvement in their care. Table 1: According to the Health Research Board (HRB), in 2015: • Almost 12% of all admissions for under 18s to Irish psychiatric units and hospitals had a primary diagnosis of eating disorders. • Females accounted for 87% of all admissions of those affected by eating disorders. The aim of the project is to develop a cross-hospital (OLCHC-Temple street- National Children’s Hospital Tallaght) multidisciplinary guideline or consensus for the treatment of the acute admission for eating disorders. It is a multidisciplinary approach with cross hospital involvement. There is another link with the United Kingdom, in that Dr Barrett has been asked to sit on the Junior MARSIPAN Committee in the UK; voicing Irish needs in the development in these guidelines. The Junior MARSIPAN working group was formed to develop guidelines for young people with anorexia nervosa to complement the report from the MARSIPAN group (CR162. MARSIPAN:

Management of Really Sick Patients with Anorexia Nervosa) which addresses the care of adult in-patients with anorexia nervosa. The rationale for a separate document is that the definition of very sick patients with anorexia nervosa differs in young people, because serious underweight varies with age and gender; other aspects of risk differ in young people (e.g. blood pressure norms); consent and capacity are addressed within different legal frameworks for young people than adults; there are differences in service organisation for specialist child and adolescent mental health services (CAMHS); and paediatric services have a central role in the care of young people. The Eating Disorder Paediatric group meets on a monthly basis to discuss various topics raised on the agenda. Some of the key items to be outlined in the guideline include: Acute assessment and treatment on presentation to emergency department Refeeding: and the rationalization of medicines and treatment in this area Roles within the MDT Nutritional assessment and input Education and Training Information to give families Care plan and ward treatment This project is the first of its kind in the field of eating disorders in child psychiatry. With limited services allocated for child psychiatry as well as a lack of

guidance for both community and hospital services, the team felt that it was imperative that we endeavour to develop clearcut and a consistent approach to the treatment of vulnerable adolescents with eating disorders. Until recently, there were no figures available on the numbers of Irish teenagers with eating disorders. Consequently, a large-scale study, Eating Problems in Children and Adolescents, EPICA, (McNicholas) took place across 52 schools in Ireland and 3,138 teenagers were screened for the presence of eating disorder symptoms. From this data, it was found that nearly 11% of the girls had significant eating concerns and 1.2% of girls were identified as being ‘at risk’ of Anorexia Nervosa. This study found that in general those with pathological eating concerns were more overweight, exercised less when compared to peers who did not have eating concerns and used dieting and vomiting as a means to monitor weight. They were also more likely to be dissatisfied with quality of life, friends and academic performance and were more depressed than those not preoccupied with weight and shape. They were also more likely to be adversely affected by the media portrayal of ideal weight and shape. Bulimia Nervosa is more common than Anorexia Nervosa and affects approximately 1% of female adolescents. About 30% of people with Bulimia will have had Anorexia Nervosa. Frequently, young people with Bulimia describe a long history of dietary problems. The peak age of onset tends to be later than for Anorexia Nervosa, occurring in late adolescence and early twenties. In the EPICA study of 3,138 Irish students, 1.5%

• Up to 200,000 people in Ireland may be affected by eating disorders. • An estimated 400 new cases emerge each year, representing 80 deaths annually. A Vision for Change: Report of the Expert Group on Mental Health Policy (2006). Source Roisin says, “This project is innovative in its cross-hospital need for patients to be treated in acute setting. The aim is not to initiate a new service, but use the limited resources we have in our current service to help deliver the best possible approach to patient care and patient safety. Ultimately the project and working group is about developing the service to help healthcare professionals in the community and in the tertiary centres, and ultimately help the vulnerable patients. “The project although in its infancy is enthusiastically received and ongoing work is to continue throughout the next few months. “ Speaking on behalf of the team, Roisin Gowan, Senior Dietician and Chair of the Group who commented, “It is a privilege to be able to accept this Award. Our project is a collaboration of three hospitals; Tallaght Hospital, Temple Street Hospital and Our Lady’s Hospital Crumlin. “I am delighted to accept this Award on behalf of the teamwork behind its success. Quite often we as professionals can be immersed in our daily work in enhancing the care of our patients and streamlining services for our colleagues and peers that the quality does not get recognised.”

Sponsors of the Shire Excellence in Child Psychiatry of the Year 2016 - Hospital Professional Awards Professional Top100 - 2016 • HPN


HPN Awards: Roche Oncology Pharmacist

Delivering Care for the Oncology Patient Grant Carroll, Chief II Pharmacist and Aseptic Services Manager, Beaumont Hospital

trend poses unique risks and challenges for Oncology Units, which have traditionally focused on intravenous therapy. Like intravenous therapy, OAMs often have a narrow therapeutic index and complex dose calculations and adjustments are required. In addition, OAMs pose a particular risk in Ireland as the ‘high-tech’ prescription is often written in hospital, but dispensed in community pharmacy. Errors can result in serious consequences. Therefore, there is an ongoing effort to improve patient safety by ensuring correct prescribing of OAMs. As an Oncology Pharmacist, Grant Carroll is committed to maintaining a focus on improving both the patient’s care, and the patient’s experience while in Beaumont Hospital. As such, he has suggested, and helped to implement efficiencies on the Day Ward, such as rapid infusions of both rituximab and bevacizumab decreasing the length of patient time on the ward. Currently he is heavily involved in an interdepartmental LEAN review of all the processes used to deliver services to oncology and haematology patients in Beaumont Hospital. Grant Carroll joined Beaumont Hospital Pharmacy Department in September 2012, taking up the post of Chief II Pharmacist as Aseptic Services Manager. He had already worked for five years as a Senior Pharmacist in this same specialist area in St. Vincent’s Hospital, giving him a sound basis on which to build on in this post. His work in this field and in enhancing oncology services within the hospital led to him being awarded the Roche Oncology Pharmacist of the Year Award for 2016 at the annual Hospital Professional Awards.

Speaking about the vital role Oncology Pharmacists play in the hospital setting he says, “The Pharmacist working in the field of cancer medicine is an essential part of the multidisciplinary team, they provide invaluable clinical, aseptic compounding and regulatory knowledge that ensures our patients are treated safely and efficiently.” Grant completed his M.Sc focusing on oral chemotherapy while working in St Vincent’s Hospital. He continued demonstrating the beneficial role of Oncology Pharmacist’s involvement in this area while in Beaumont Hospital. Grant introduced a verification process for High Tech prescriptions for oral anti-cancer medicines and the Senior Oncology Pharmacist, which involved a detailed check of each prescription and liaising with Community Pharmacists to ensure the safe use of these highrisk medicines. This service was supported and encouraged by all of the Consultant Medical Oncologists. A database of all prescriptions reviewed was maintained, allowing further research on oral anti-cancer

medicines, thus demonstrating pharmacy input and Grant’s poster on this subject won a Highly Commended Award at the HPAI Conference in 2014. A multidisciplinary review of this data was undertaken last year, and the results of this research received a resounding endorsement from the Irish Society of Medical Oncologists, when Grant was the only Pharmacist invited to present and at its annual conference in 2015. As further evidence of the acknowledgement of the importance of a Pharmacists involvement in the area of oral anticancer medicines by the medical community, Grant was awarded the top prize of a substantial travel bursary in his presentation’s category. Further development of this work has been put on hold due to resource constraints. Grant has written and presented an IPU Academy CPD Course for Community Pharmacists on Oral Anticancer Medication (OAM) which was used by tutors all over the country in order to increase awareness of the risks associated with these high risk drugs. Over the past decade, there has been a significant increase in the number of OAMs available. This

In Beaumont OAMs are prescribed in specialist clinics, and last year Grant and his team within the Aseptic Unit assessed the value of including a pharmacy verification process into the clinic. All prescriptions were copied and verified by ACU staff using the British Oncology Pharmacy Association (BOPA) standards prior to being sent to community pharmacies. Any errors and the resultant interventions are prospectively logged. The aim of the work was to examine adherence to best prescribing practise and to quantify and characterise prescription errors and pharmacy interventions. A multidisciplinary approach to care has been applied in a variety of settings in clinical oncology. Although pharmacists’ contributions to oncology have not been fully recognised, it is evident that they have an expanded role on oncology teams. Introducing individualised treatment plans, monitoring chemotherapy together with nursing staff, and providing patient education about medications could serve as starting points for introducing Clinical Pharmacists to multidisciplinary oncology teams. Oncology Pharmacists play an important role in the delivery of HPN • Professional Top100 - 2016


HPN Awards: Roche Oncology Pharmacist care for individuals living with cancer. As an integral part of the cancer care team, they represent a broad range of expertise and levels of practice, skills and responsibilities. They are involved with the care of cancer patients at all phases of their treatment; from assessment and diagnosis, to treatment decisions, medication management, symptom management and supportive care, and finally with survivorship programs at the completion of their treatment. They work with other care providers to ensure a current and accurate medication list, select the most appropriate therapy, monitor the effects of medications prescribed, and manage the adverse effects that often accompany cancer treatment. As the care of cancer patients continues to be challenged with high cost therapies, medication shortages, regulatory requirements and dwindling reimbursement, the Oncology Pharmacist is heavily relied upon to provide support for the clinical team in an effort to improve overall cancer care and patient quality of life.

nce 1896. The Aseptic Unit staff, led by Grant, have been instrumental in the implementation of the ARIA electronic prescribing system into Beaumont’s Cancer Centre Day Unit and were responsible for building the regimen library for the system, which involved: • Inputting and validating over 100 treatment protocols • Developing SOPs covering protocol control, input and validation • Co-ordinating with the Oncologists to ensure all required protocols were up to date and evidence based • Assessing and standardising current practise in relation to supportive medication The introduction of the electronic system improves medicines governance and supports the ACU in providing a safe and efficient service in spite of the increased number and complexity of chemotherapy treatments.

Advantages of Electronic System over Paper Based System

Old paper based System

Electronic System

Information often incomplete or missing on paper based prescription templates with spaces to complete doses and frequencies.

All information automatically populated from electronic patient record; prescription cannot be ordered until all information present.

BSA and Dose calculations manually calculated using desk-top/on-line calculators, rounding issues common.

BSA and Dose calculations automatically completed and doses rounded to measurable quantities.

Lack of information for clinical checks of prescriptions as notes held on Oncology Day Ward

Notes available in the Pharmacy Department from Electronic Patient Record.

Prescription templates often changed or out of date, leading to confusion around which protocol is current and appropriate supportive medication, fluids and infusion rates

Orders can only be completed using locally approved protocols which must be entered by a Pharmacist, checked by a 2nd Pharmacist and approved by a Consultant Oncologist. Protocols include all drugs, fluids and supportive medications.

Paper prescriptions delivered by hand to the Pharmacy Department, leading to delays in release of chemotherapy

Prescriptions available in the Pharmacy Department as soon as they are ordered, limiting delays and reducing patient waiting times.

Data extraction is manual or limited by fields in pharmacy system

construction of two new purposebuilt negative pressure isolators for the Unit, which should arrive later this year.

requirements) his department, his staff and has lead and inspired his team with enthusiasm and drive in the last four years.

He has also succeeded in securing extras computers in the Aseptic Unit, which are required for the roll out of the Electronic-Prescribing System this year. Grant has liaised closely with the medical oncologists to ensure that all the chemotherapy regimens have been imputed correctly and validated before the system goes live.

He adds, “The efficiency measures our team put in place mean that we have been able to deal with the increased workload without compromising patient safety, access and wait times, in-fact turn around times in the unit have improved. We have also managed to save money for the hospital by being less reliant on outsourced products.

Grant is committed to the development of the Pharmacy profession, and he is currently a member of the HPAI Executive Committee. He has also served on NCCP Committees in the past and is currently on the Systemic Treatment Programme Steering Committee.

chemotherapy out of hours in

“I guess you could say the field of oncology pharmacy does not have the highest profile, we are a way from the front line so it is terrific to be recognised for the work that we do. It is equally important to recognise that it is all part of a huge team effort; we all work together to ensure that cancer treatment, and the best in cancer treatment, is delivered to the patients as safely and efficiently as possible.”

develop a cost saving strategy (approx. ¤15,000 pa) for future out of hours chemotherapy

In looking to the future, he adds “The delivery of public healthcare within the limited resources we

Grant has proven his relentless

commitment to his profession, A tradition of advancing science and his patients (which saw him prepare

Co-ordinating Resources

medicine. Then, now and in out theof hours future. an emergency and

With the future in mind, and with the ever-increasing workload under his responsibility, Grant is co-ordinating the design and

Wide range of reports available covering all aspects of treatment and patient characteristics. Improves efficiency when reporting data and increases opportunities for real-world practise based research are given remains a challenge. Despite this being an award for an Oncology Pharmacist, there is still no recognition of Hospital Pharmacist specialisation within the Irish public healthcare system, therefore in some sense there is no such thing as an Oncology Pharmacist. There are many highly qualified and motivated Hospital Pharmacists working in the area of cancer care, and other areas, who continue to wait for this recognition, Infrastructural and resourcing of course continue to be a challenge as many Hospital Pharmacies face into another year with aging and unreliable equipment and staffing inadequacies. There is a huge opportunity for the HSE to harness the unique skills and knowledge of Hospital Pharmacists by implementing the long-awaited Career Review and building on much of the great work already underway.” Grant Carroll, Chief II Pharmacist, Aseptic Service Manager, with Beaumont Hospital won the Roche Oncology Pharmacist of the Year Award 2016.

Sponsors of the Roche Oncology Pharmacist of the Year 2016 Hospital Professional Awards Professional Top100 - 2016 • HPN


Improving lives since 1896.

A tradition of advancing science and medicine. Then, now and in the future.


HPN Awards: Innovation & Service Development

Exploring innovation in Lithium Therapy Optimisation St Patrick's University Hospital Chief Pharmacists Ciara Ni Dhubhlaing and Clare Butler

an efficient and easily accessible multimedia format. The objectives here were two-fold: • To develop an on-line resource package that is accessible to all service users, carers and family relatives providing information on lithium therapy. • To develop core content and literacy proofing using NALA principles The information was prepared with multidisciplinary input and based on National Patient Safety Agency(12) recommendations, consultation and evidence based practice.

Studies have identified a number of patient related factors that may influence poor adherence to lithium therapy including receiving inadequate information about lithium treatment and blood monitoring or not assimilating the information given(1-3). It is suggested that between 30–50% of medicines are not being taken as intended(4) and a recent survey found that more than half of patients with mental health conditions report receiving insufficient information about medicines they are asked to take(5). In addition, it has been reported that 1 in 5 Irish people are not fully confident that they understand all the information they receive from their healthcare professional and 43% said they would only sometimes ask their healthcare professional to clarify the information if they did not understand something they had said(6). Incorporating the NHS England guidance on medicines optimisation(7) Senior Pharmacists

Professional Top100 - 2016 • HPN

with St Patrick’s University Hospital Ciara Ni Dubhlain and Clare Butler explored a cost effective intervention to optimise medicines use and ensure it is deliverable and affordable on the scale required for their target demographic, a large number of service users in rural/urban areas throughout the country. E-learning packages have been incorporated in training and development in a broad range of areas and deliver a high quality interface for patient education(8) without the difficulties associated with geographical barriers to service provision. Following Department of Health recommendations to address and prioritise health literacy when developing educational and information intervention(9), the core content was reviewed using the National Adult Literacy Agency (NALA)(10) tools to improve readability and understanding of materials and evaluated for readability scores using the Flesch-Kincaid Readability Test(11).

Setting out Aims and Objectives Lithium (Eskalith, Lithobid) is one of the most widely used and studied medications for treating bipolar disorder. Lithium helps reduce the severity and frequency of mania. It may also help relieve or prevent bipolar depression. Studies show that lithium can significantly reduce suicide risk. Lithium also helps prevent future manic and depressive episodes. As a result, it may be prescribed for long periods of time (even between episodes) as maintenance therapy. Lithium acts on a person's central nervous system (brain and spinal cord). Doctors don't know exactly how lithium works to stabilize a person's mood, but it is thought to help strengthen nerve cell connections in brain regions that are involved in regulating mood, thinking and behaviour. The e-learning package aims to provide a supplementary resource using visual and verbal methods to offer diverse delivery of medicine related information in

The content was reviewed by peers, specialist psychiatrist, doctors and nurses. The content was submitted for review by service users through the St Patricks Mental Health Services (SPMHS) consumer council group. The language and content was submitted for health literacy testing via Flesch-Kincaid Reading Ease Readability Test and incorporated the NALA literacy proofing tools for health literature. A literacy age of at least 13-15 years was the minimum standard. The e-learning company Dillon Productions provided the technology and support to provide the on-line interactive package. The multimedia resource included audible narrative, story board video clips and expert interviews. The e-learning package addressed core learning outcomes in different modules that provide a consistent and simple navigation system allowing the user to go ‘forward’ or ‘backward’ or ‘jump’ between sections. The multimedia material included written bullet points with an


he programme was launched in June 2015 and made available on the website of St Patricks Mental ealth Services ( http://www.stpatricks.ie/lithium). There was a short user satisfaction survey at the end f the package to evaluate the user’s experience. Information was collected for one year (July 2015 –July 016) during that period 36 people completed the user satisfaction survey. Figure 1 User experience of the e-learning package

Figure 1 User experience of the e-learning package

The information is easy to understand

3. Simpson J, Benbow SM. Recent audit of people taking lithium. Psychiatry Bulletin. 1999; (23): 241-246.

Strongly disagree

The infromation is clear

Disagree

The e-learning package was a better information resource than a leaflet The e-learning package has increased my understanding of lithium treatment

Agree

4. World Health Organization. Adherence to long-term therapies: Evidence for action. 2003. Available from: http://www.who. int/chp/knowledge/publications/ adherence_report/en/ Accessed 21/06/2016.

Strongly Agree

0

5

10

15

20

Figure 2 Demographic of e-learning package users Figure 2 Demographic of e-learning package users

Number Service user Healthcare professional Family Member Carer Friend

audible narrative, story board method of delivering medicine Increasing Knowledge and related information to service Understanding video scenarios and expert users throughout the country video interviews. At the end of The results suggest that providing without the difficulties associated the package there is a survey lithium education through with geographical barriers to evaluating the user’s knowledge ggest that providing lithium education through a multimedia withservice a combination of a multimedia format with format a provision. and understanding of the core combination of visual and verbal bal methods increased knowledge and understanding of lithium treatment for over 86% of learning outcomes and the The use of e-learning packages methods increased knowledge and nd 80%possibility agree that they find it a better information resource than leaflets. of ‘jumping’ back is now being considered by the understanding of lithium treatment to a section to review again. It organisation as an education and for over 86% of participants and conveniently allows users professionals to training 80%accessing agree that information they find it a better participants were healthcare which was an resource for employees for ‘resume’ to a specific point at a Mental Health Commission training information resource than leaflets. utcomefuture as the package was intended as a resource for service users, theirand carer’s andSafety Training, and Fire and time and the modules can A thirdare of the participants unclear be whether themultiple healthcare employed by SPMHS or further otherwise but the service user education accessed times. professionals There were healthcare professionals packages may be developed for is ‘further information’impact resources fessionals may positively raising awareness of optimising lithium therapy. accessing information which other medicines. linked to the navigation system. was an unexpected outcome The Pharmacy team at St Patrick’s as the package was intended The programme was an launched in se packages can provide accessible multimedia method of delivering medicine related University Hospital led by Ciara as a resource for service users, 2015 and made available on o serviceJune users throughout the country without the difficulties associatedand with geographical Clare won the Innovation their carer’s and families. It is the website of St Patricks Mental vice provision. and Service Development Award unclear whether the healthcare Health Services ( http://www. 2016 at the recent Hospital professionals are employed stpatricks.ie/lithium). There was a Professional Awards. by SPMHS or otherwise but user satisfaction survey at earningshort packages is now being considered by the organisation as an education and training the uptake by professionals References the end of the package evaluate mployees for Mental HealthtoCommission training andimpact Fire and Safety Training, and further may positively raising the user’s experience. Information 1 Glover KJ, Lawley D. How safe is awareness of optimising ducation packages may be developed for other medicines. was collected for one year (July lithium prescribing? Audit of a local lithium therapy. 2015 –July 2016) during that prescribing framework and patient period 36 people completed the The use of these packages can survey. Psychiatry Bulletin. 2005; user satisfaction survey. provide an accessible multimedia (29):98-100.

Awards Hospital Professional

2017

2. Egan TM, Grigor JM. Monitoring lithium treatment. British Medical Journal. 1992; (305):52-53.

5. Care Quality Commission (CQC). Results of inpatient survey 2015. 2015. Available from: http:// www.cqc.org.uk/sites/default/ files/20160608_ip15_statistical_ release.pdf Accessed 21/06/2016 6. Merck Sharp Dohme (MSD)/ National Adult Literacy Agency (NALA). Health Literacy Survey in Ireland. 2007. Available at: http:// www.healthliteracy.ie/literature. Accessed 21/06/2016. 7. Royal Pharmaceutical Society. Medicines Optimisation: Helping Patients to Make the Most of Medicines. Good Practice Guidance for Healthcare Professionals in England. 2013. RPS. London. 8. Fox MP. A systematic review of the literature reporting on studies that examined the impact of interactive, computer-based patient education programs. Patient Education and Counseling. 2009; (77): 6–13. 9. Department of Health. Healthy Ireland – A Framework for Improved Health and Wellbeing 2013-2015. 2013 Available from : http://health.gov.ie/wpcontent/uploads/2014/03/ HealthyIrelandBrochureWA2.pdf. Accessed 21/06/2016 10. National Adult Literacy Agency (NALA). Plain English Guidelines. 2005 Available from: http://www.nala.ie/index.cfm/ section/publications/top/1/ext/ Publications/search_pub/1/ Accessed 21/06/2016 11. Flesch RF. A new readability yardstick. Journal of Applied Psychology. 1948; (32):221–333. 12. National Patient Safety Agency: Safer lithium therapy. Patient Safety Alert, NPSA/2009/ PSA005, 1st December 2009.

Hospital Professional Awards 2017, Saturday September 16th, 2017, Clayton Hotel (Burlington) Dublin HPN • Professional Top100 - 2016


HPN Awards: Daiichi Sankyo Pharmacy Team

Success in introducing a new Medicines Management Service

Back row: Bernadette Connaughton, Imelda Corcoran, Linda Maher, Cormac Cullen, John O'Byrne, Niamh Kilcullen, Jennifer O'Meara, Ollie Fitzgerald, Temitope Agebele, Aidan Nolan, Mick Gregg, Raj Sasidharan. Front row: Aline Chirtullescu, Caroline Monahan, Sarah Fay, Lorraine Cooper, Sharon Curran-Rae and Trish Dalton

The Pharmacy at Tallaght Hospital have, since 2015, been involved in the introduction of a Medicines Management Technician (MMT) Service based. Their work in this field has been widely recognised and was awarded the title of Daichii Sankyo Hospital Pharmacy Team of the Year at the 2016 Hospital Professional Awards. The team are motivated to ensure that the patients in Tallaght Hospital receive the best possible pharmaceutical care in a timely manner. They have all strived to make the new MMT service the success that it has become. They ensure that costs are kept to a minimum and that waste in the system is minimised in order to ensure that optimal services are proved to all our patients. All team members share this common

Professional Top100 - 2016 • HPN

goal and work together to stay motivated and achieve these outcomes. Team meetings and individual meetings with staff help to keep all motivated and allow feedback on the service, as it develops. In January of last year, the decision was made to introduce the MMT service to one ward in the hospital. Prior to the introduction this service, each ward carried a range of medications as ward stock. Nursing staff ordered non-stock medicines which were supplied to the wards as a 7 day supply labelled with the patient’s details. The MMT’s role was to ensure that medicines were ordered, supplied and managed effectively at ward level. In order to facilitate this, medication was dispensed

as original packs, which lead to a significant reduction in the dispensary workload. The turnaround time for each item in the dispensary has been reduced from 4mins 30sec to 11 sec. It is this efficiency that has generated the time to provide the MMT service to the wards without any additional staffing resource. The time saved facilitated roll out of the service to other wards in the hospital. The service is now available on 8 of the adult inpatient wards with full roll out due for completion by year end. The MMT’s visits their allocated wards each morning. They check for new patients and make a note of their medications. For all existing patients they check if there are any changes to their medication. A list is compiled of

the medication that needs to be ordered that day, checking the medication in stock on the ward as appropriate. This list is then entered on Cliniscript at ward level using a dedicated laptop. This order list prints out in the dispensary printer and is picked by dispensary staff. When the medication arrives is sent to the ward and the MMT puts the medication away in the individual patient slots in the drug trolley. This service has reduced the burden of medication ordering for nursing staff who now have more time for direct patient care. It makes better use of the skill set of both Pharmaceutical Technicians and nurses and has led to improvements in communication between nursing and Pharmacy staff, patient care, advanced roles


HPN Awards: Daiichi Sankyo Pharmacy Team to Pharmacy more promptly. This was acknowledged and became a target area for improvement for all staff in the service. All dispensary based staff have been involved by the change in service provision. Their role is predominantly in the picking of the medication for these wards. However the ordering, organisation of the dispensary and porter’s delivery rounds have all undergone significant change to facilitate the service development.

Pictured are the Tallaght team led by John O'Byrne and Niamh Kilcullen with Liz Kehoe, Senior Brand Manager, Daiichi Sankyo

for Pharmaceutical Technician’s, generated efficiencies within the system and reduced the risk of missed doses for patients. Since roll out the following objectives have been met: • Medication is supplied in original packs where possible • Unused medication is returned to Pharmacy for destruction or reuse • The storage of both stock and non-stock medications has been rearranged to ensure maximum efficiency. • The Pharmacy software system, Cliniscript is being accessed on laptops via hospital wi-fi used to electronically transmit the majority of orders to the Pharmacy. The exceptions at this time are o Orders that needed to be queried with the Pharmacisto Orders for any medication that needed to be labelled with patient details for safety reasons e.g. methotrexate. All dispensary based staff have been affected by the change in service provision. Today for the wards included in the MMT service there is no longer individual patient dispensing. The dispensary based staff have a role predominantly in the picking of the medication for these wards. The turnaround time for each item has been reduced from 4mins 30sec to 11 sec. It is this efficiency that has generated the time to provide the MMT’s to the wards and reduces the opportunities for missed doses.

Data collection was carried out over a three week period prior to the introduction of the service to a surgical ward and repeated after the service was established, in order to ascertain the impact of the project in meeting the remaining objectives of: • reduced missed doses • release of nursing time from medication related duties data collection was carried out before and after the introduction of the service to a surgical ward. Data was collected on the number of missed doses and the duration of the medication round over a three week period. Results obtained include: • Missed doses were reduced from 2.98% to 1.62%. • The duration of the medication round was reduced by 20% at for the 08:15 drug round and by 16% for the 11:30 round, equating to 9 hours of saved nursing time per ward per week.. • The number of interruptions that were made to the nurse conducting the medication round was reduced by 18.9%. • Missed doses were reduced from 2.98% to 1.62%. A nursing satisfaction questionnaire was also undertaken post implementation. It showed that nursing staff were very happy with the service and agreed that it was a very significant improvement in service, medication supply and patient care. The area highlighted for improvement was that returns could be taken back

The MMT team is led by the Pharmacy Operations Manager, Dispensary Manager and the MMT Supervisor who meet weekly to decide the high level project direction. This group also meet the CNM’s of any new ward to be included in the project before rollout and seek feedback from the CNM’s as the project progresses during and after rollout. The ability to communicate with the key stakeholders and their involvement throughout the project has been key to its success. The MMT group team meet every 3 months in order to ensure that there is clear communication between all staff members as to the direction of the project, and to communicate any decisions that have been made. The first Pharmaceutical Technicians working as MMT’s have undertaken medicines management training in the UK. Those trained have acted as mentors to their newer colleagues. This mentoring system has created a great learning environment as newer staff members are able to learn from their more experienced colleagues, over their first year. Imelda Corcoran, Medicines Management Technician at Tallaght Hospital spoke on behalf of the team. She says, “Every member of our team has a specialist skill that they bring to the table. We all work together to ensure our service offering and patient care is at the highest possible level. “As a whole unit, we feel fantastic to gain recognition and acknowledgment for the work we have carried out together, this is such a major achievement for the Pharmacy and serves to let us know what we are doing is right. We will continue to work as hard as we have been to ensure its our patients that benefit.” This project has been driven by the staff in the Dispensary in

Tallaght Hospital wishing to further enhance the services provided to the patients in the hospital. It is a novel and innovative project which has been developed using the skills and attributes of the team members to maximise the results that have been achieved. No-one person could have achieved this alone- the Medicines Management Technicians team are a true example of a Hospital Pharmacy Team of the Year with improvements in patient outcomes as their key focus. The Medicines Management Technicians Team at Tallaght Hospital won the Daichii Sankyo Hospital Pharmacy Team of the Year Award 2016. Team Members Niamh Kilcullen, Dispensary Manager John O’Byrne, Pharmacy Operations Manager Caroline Monahan, Medicines Management Technician Supervisor Patricia Dalton, Dispensary Team Leader Yvonne Sheehan, Senior Pharmaceutical Technician Purchasing Linda Maher, Top-up Supervisor Medicines Management Technicians: Jennifer O’Meara Fiona Kirwan Temitope Agbele Jennifer Mackey Imelda Corcoran Cormac Cullen, Deputy Dispensary Team Leader Aidan Nolan, Pharmacy Aide Dispensary Based Pharmaceutical Technicians: Anita Connolly Maher Reji Sasidaharan Bernadette Connaughton Blathnaid McIntyre Lorraine Cooper Sarah Fay Sharon Curran-Rae Alina Chirtulesco Pharmacy Porters: Oliver Fitzgerald Michael Gregg

Sponsors of the Daiichi Sankyo Pharmacy Team of the Year 2016 Hospital Professional Awards Professional Top100 - 2016 • HPN


HPN Awards: Idis Hospital Pharmacist

Michael continues to put Pharmacy at the forefront

Michael Fitzpatrick, Chief Pharmacist, Our Lady's Children's Hospital, Crumlin Michael Fitzpatrick, Head of Pharmacy Services at Our Lady’s Children’s Hospital and Pharmacy Lead for the new National Children’s Hospital has demonstrated consistent leadership throughout his career as both a Hospital Pharmacist and a mentor to colleagues. Every staff member within OLCHC agrees that he is a crucial and central figure around which their Pharmacy team is centred therefore enabling and driving them to work above and beyond their scope of practice to develop the role of the Paediatric Pharmacy in Ireland.

It is this passion and he strives to put Pharmacy at the forefront and drives the team to be the best Pharmacy department that they can be. Michael Fitzpatrick joined the Pharmacy team here at OLCHC ten years ago and in that time he has accomplished a vast amount both within and outside of the hospital setting. He has been the leading figure on a number of major changes in the department and within the paediatric hospital circuit. Our Lady's Children's Hospital, Crumlin is Ireland's largest

paediatric hospital. Our Lady's mission is to constantly improve the health and wellbeing of children and adolescents in a safe environment which is driven by quality healthcare and supported by excellence in Knowledge, Education and Research. In 2014 the hospital had 34,770 emergency attendances, 17,700 day cases, 10,467 in-patient admissions, 74,843 outpatient attendances and performed 14,744 surgical procedures. It is Ireland's largest paediatric hospital and is responsible nationally for the provision of the majority of quaternary, tertiary and secondary healthcare services for children. It

is the national centre in Ireland for a range of specialities including children's childhood cancers and blood disorders, cardiac diseases, major burns, cystic fibrosis, clinical genetics and rheumatology. The hospital is also involved in the teaching of medical personnel. Undergraduate students from University College Dublin, The Royal College of Surgeons in Ireland and Trinity College Dublin receive training in Paediatrics at Our Lady's Hospital. Michael is a diverse character; having previously worked as a pharmacy technician; followed by some time in the private

HPN • Professional Top100 - 2016


HPN Awards: Idis Hospital Pharmacist hospital sector and then eventually evolving to his role as the Head of Pharmacy Services in OLCHC. “We are involved in clinical trials and ongoing evaluation of medications for use with children, along with education, training and research relating to pharmacy, medicines and therapeutics. Pharmacy also retains the traditional and important role in the cost-effective procurement, quality testing, safe storage and dispensing of medicines,” he says. “We are also constantly investigating new technologies and the positive impact they can have in patient care, including e-prescribing, robotics and automated dispensing technologies, app development and so on. “I manage all these activities on behalf of OLCHC to ensure our patients receive a standard of pharmaceutical care that compares favourably with international paediatric centres of excellence. “There is a huge amount of operational requests and pharmacy-related issues to deal with on a continuous basis. Crumlin is so dynamic, you often don’t know what’s coming next, and may have to rearrange priorities at very short notice.” Interestingly, he has an extensive background in Information Technology. Having completed multiple courses and upskilled in IT this has been at the forefront of his development of the department in OLCHC over the last few years. Developing Clinical Opportunities He was the one of the first in the country to lead in developing a commercially available formulary application back in 2011. He had a vision for the future of Smart Phones and IT which HSE only realised more recently. He was also one of the first Chief Pharmacists to introduce a deputy Chief II in Informatics; knowing that developing the hospital IT development would be lost without a Pharmacy lead at the forefront. Michael has been a crucial and influential figure in the introduction and maintenance of the OLCHC formulary app, which has enabled safer and better access to

Michael Fitzpatrick, Chief Pharmacist, Our Lady's Children's Hospital, Crumlin

paediatric doses and providing all healthcare professionals with easy access to this information. His exceptional I.T. skills combined with being an eagle-eyed pharmacist make the perfect candidate to undertake the huge projects with which he has been involved.

RCSI pharmacy students will be afforded the opportunity to undertake experiential learning in a clinical setting under the tutelage and direction of experienced pharmacy practitioners where students will enhance their clinical pharmacy knowledge and experience.

The new children’s hospital is a huge project in which Michael has been involved with since the get-go. It is his determination and fight to ensure that he has been involved from the development stage with this project. More recently he has been appointed to the National Children’s Hospital Board as the Pharmacy Lead. Michael will most certainly ensure that Pharmacy services are at the forefront of the new hospital taking into consideration providing a diverse clinical service; world class compounding service; and developing an outpatient service for paediatrics.

This new mutually beneficial collaboration with RCSI School of Pharmacy will facilitate access to innovative educational initiatives at RCSI, enabling the exploration of novel training programmes tailored specifically to the needs of the hospital pharmacy department staff and enabling the development of a mutually agreed, mutually beneficial translational research strategy in paediatrics.

Memorandums of Understanding In 2015 the Pharmacy department at OLCHC signed a Memorandum of Understanding with the Royal College of Surgeons Ireland; bringing paediatric Pharmacy education to the forefront of Pharmacy education. Paediatrics is always an overwhelming and intimidating discipline so introducing it early into the curriculum is essential for future development. The aim of the partnership is to enhance paediatric care through the delivery of practice-based research. The research activity will include evaluation of services and initiatives to promote safe and effective use of medicines and ultimately to conduct clinical trials which will provide an evidence base for improved therapeutics and interventions in children.

Introducing a new Joint kardex to this paediatric hospital was not a task to be taken lightly. Along with a strong team of pharmacists and technicians, Michael was involved in the design and approval of a new, innovative, and much needed kardex to meet the requirements of a complex, vulnerable and unique cohort of patients. Continuing Professional Development Michael is keen to upskill all of his staff members; and is always very encouraging. The team are focused on liaising heavily with their paediatric counterparts in the United Kingdom to ensure they can provide the best possible service to patients. The Neonatal and Paediatric Pharmacists Group (NAPPG) is at the forefront of practice and hiring graduates with an excellent skill mix. Although this may seem like a huge workload for one person to take on, Michael is simultaneously undertaking a PhD with the University of Birmingham himself; with the ultimate aim of

the project to help paediatric burns victims. Managing people is a massive component of the role of Chief Pharmacist. Michael has exceptional communication and people skills and this is evident from the respect and hard work that is seen from his staff. His ability to diffuse what may seem like an impossible or difficult situation and offer solutions and advice just goes to show how much the department relies on his invaluable experience. He adds, “Each week is busy but we are providing a vital service that improves a patient’s quality of life. The medication management of a child is highly complex and pharmacy is an integral part of this. I feel privileged to work with my pharmacist and technician colleagues and the broader family of healthcare professionals, management and support staff. “Their commitment and willingness to go the extra mile for our patients makes OLCHC the amazing and unique place that it is. Working for children is definitely the best part of the job; the way they tackle adversity with such positivity can be very humbling. However, there can also be some difficulties. For example, trying to manage a complex service with limited resources can be very frustrating. Management in OLCHC are very supportive of pharmacy and recognise what it can deliver from a safety and cost perspective. But having said that, there are budgetary restraints across the public health service and I must operate as best I can within this.” Michael Fitzpatrick, Chief Pharmacist with Our Lady’s Children’s Hospital Crumlin won the Idis Hospital Pharmacist of the Year 2016 Award.

Sponsors of the Idis Hospital Pharmacist of the Year 2016 Hospital Professional Awards Professional Top100 - 2016 • HPN


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HPN Awards: Medisource Hospital Pharmacy Technician

Running that extra mile for Technicians

When she is not trying to improve the Pharmacy department and the roles of all members of the team, she often runs ten kilometres or participates in various events for charity.

Leonor O'Connor, Senior Hospital Pharmacy Technician, St James's Hospital

Leonor O Connor has been working in the pharmacy in St James's Hospital for the last 14 years and has been described as someone who constantly motivates her colleagues and is continuously working to improve the role of the Pharmacy Technician within SJH and also through her volunteer work with the National Association of Hospital Pharmacy Technicians (NAHPT). It is evident that pharmacy technicians are playing an increasingly important supporting role as pharmacists are increasingly spending more time with patient consultations and engaging local stakeholders. The shift in emphasis from dispensing to healthcare provision has meant that the wider pharmacy team has to pull together Pharmacy Technicians capture the essence of this in everything that they do.

pharmacy department for the annual stocktake. Over the last two years she has organised direct delivery services for IV fluids and up-skilled the supplies officers to manage the service at ward level. Currently Leonor is a part of a team who are preparing for the major systems changes due to happen with relocation of the Pharmacy department and the introduction of robotics.

Leonor has been working as a Hospital Pharmacy Technician for over twenty years. She previously worked in the NHS for 8 years, before returning to work in Ireland. She began her training by completing the Pharmacy Technician Diploma in Trinity College Dublin, the Dispensary Checking Technician course and also a Higher National Certificate in Pharmaceutical Sciences which is a two year course in management and clinical studies for senior technicians. During her time in Scotland within the NHS she was a designated medicines management technician and during that time undertook a project for setting up a ‘Patients Own Drugs’ system, which involved assessing patients own drugs for use within the hospital during their stay. During her time with St James's she has aided in the enhancement of the role of a Pharmacy Technician and has completed many courses within the hospitals training facilities and encourages others to complete courses also.

She co-ordinates monthly staff meetings and education sessions. She is always conscious of health and safety of her colleagues and will liaise with companies when She is an active committee issues arise e.g. pallet sizes, member and the current newsletter editor of the excessive delivery weights. Leonor introduced the idea of online ordering that was simple and aided in preventing

Some initiatives Leonor has led include: Set up of an Acute Medical Assessment Unit Ward based Pharmacy Technician service. Senior pharmacy technicians order the non-stock medicines for all patients in the acute medical assessment units. This assists the senior clinical pharmacists to ensure an effective timely medicine supply. This service has had many benefits including: • Reduction in length of time taken to issue non-stock drugs to ward. • Highlights problems or potential prescribing errors to ward pharmacist as soon as possible. • Reduces delays in treatment due to missed doses both on admission and transfer. • Reduces wasteful dispensing of non-stock medicines by preventing repeat dispensing on transfer.

phone calls with queries.

Leonor currently manages the Pharmacy stores area at St James's Hospital. She ensures sufficient staff levels at all times, manages receipt of ‘goods-in’ and orders appropriate stock levels of dressings, feeds and fluids for the hospital. She also manages the archiving of all prescriptions and documentation for the entire pharmacy department, and plays an essential role preparing the

Leonor introduced the idea of online ordering that was simple and aided in preventing excessive phone calls with queries The above screen is available for nurses to select what type of items they require.

Professional Top100 - 2016 • HPN

National Association of Hospital Pharmacy Technicians.


Leonor O'Connor pictured with the Hospital Pharmacy team

Online pharmacy stores ordering system

Quality Initiative Workshop within St James's Hospital.

Leonor was involved in the initial set-up and continuing maintenance of an online pharmacy stores teleordering system which allows ward staff to view and order pharmacy stores items, including dressings, nutritional products and IV fluids efficiently.

SJH Pharmacy Department is about to undergo a huge change in the coming months. It is relocating, adding an offsite stores area and introducing robotics. Leonor has been happy to take a lead role reviewing all current roles and planning for all the changes and expansion in roles that will come with the new department.

Development of Supplies Officer Role She has aided in developing the role of the supplies officers. They are now fully trained in ‘goods-in’ procedures, use of computer and online teleorder systems and ward fluid top-ups. She has been involved in hospital quality initiatives and submitted a project this year on Time Management and the development of the pharmacy technician service. This project aimed to rank ward top-ups according to difficulty and match them to the technician with the appropriate experience resulting. This was presented at the NAHPT annual conference and at a

She always encourages people to study more, to complete courses, participate in training, and to treat all people with respect. She once told a colleague that as she worked in a hospital it was her responsibility to help any patient that stops her, or who seems lost and unable to follow directions and that they should help them to get their, that their job is for the patients, and not just the patients on their ward, but any that team members come into contact with. Leonor convinced colleagues to join the NAHPT and become committee members. One in particular took on the important role of membership co-ordinator,

which together with the editor and co-ordinator, aids in the smooth running of the regular production and postage of NAHPT newsletters. This has helped them enormously as it has been a constant learning curve e.g. new protocols, products etc. and they can now apply these skills to their day-to-day work. She has been an active member of the association for the last three years. She does this voluntarily and sacrifices many evenings to attend meetings in preparation for the annual conference. When she is not trying to improve the Pharmacy Department and the roles of all members of the team, she often runs ten kilometres or participates in various events for charity. Leonor commented, “I have been working in a Pharmacy Technician for over twenty years and I am delighted to receive this Award for my efforts. The role of Pharmacy Technician is changing in many ways as we move towards an era of new technology and the automation of our processes. There are exciting times ahead

for us to be greater involved in an expansion of our role assisting in the work of the clinical pharmacists at ward level and I am very proud to be a part of that. “I would like to thank Medisource for their continued support of our profession, generally and through their continued sponsorship of this Award category highlighted the valuable work technicians bring to the hospital environment.” Paul Boland, Managing Director of Medisource added, “Many congratulations to Leonor on her very deserving win of this Award. She has developed the role extensively for the hospital pharmacy technician and I am delighted for her. We chose this Award because we understand that Technicians are key part of the pharmacy team and the work they do towards helping improve patient care and their role is often not seen.” Leonor O’Connor won the Medisource Hospital Pharmacy Technician of the Year Award 2016.

Sponsors of the Medisouce Hospital Technician of the Year 2016 Hospital Professional Awards HPN • Professional Top100 - 2016


HPN Awards: Multidisciplinary Award

Working together on treatment and outcomes

Back row: Emma Crowther (Physio), Eleanor Alexander (Physio), Sinead Cunneen (Dietician), Martina Boyle(Speech Language) Paul Moloney(Occupational Therapy), Nuala Doyle (Pharmacy), Paula O’Connor (Dietician), Fiona Keogan (Physio), Anne Marie Garvin(Pharmacy) Front row: Ciara Reddy (Pharmacy), Helen Heery (Physio), Aoife Molloy (Social Work), Yvonne O’Riordan (Occupational therapy), Mairi Donald (Pharmacy) The Multidisciplinary Award was won by the Pharmacy team at Beaumont Hospital. Treatment of patients is, in most cases, a combined effort of several individuals and it is recognised that the outcome of a procedure is optimal when the professionals do indeed work together as a team. The team at Beaumont displayed that and more with their entry which focused on their hospital development project, which commenced in 2015. Beaumont Hospital embarked on a hospital improvement project in 2015. The focus was on the elderly, the highest numbers of patient admissions and provision of care. The initiative and challenge was to innovate, initially with the staff they had, change their service for the elderly, improving the quality of care provided, in particular, to the FRAIL elderly in the Emergency Department (ED). Fraility is deemed positive if one of the following list is present: Professional Top100 - 2016 • HPN

• Functional impairment,

2. Day Hospital review

Patients Seen

• Resident in a care home,

3. Admission and hand over to the Frailty Intervention Therapy (FIT) team which includes all of the professions listed above.

Prescribed Drugs Reviewed

• Acute confusion or delirium, • Immobility or falls in last 3 months, • List of 6 or more medicines. The professional teams met regularly in the summer of 2015 to unravel the sequence of steps a frail elderly patient may go through on arrival at the ED. Complex older patients are less likely to be discharged from the acute medical services having significantly longer length of stay in hospital if admitted. Chief Pharmacist Nuala Doyle explains, “We recognised the need to identify these patients and develop an improved service where the patient’s rehabilitation intervention commences in the ED. Hence a team of Health and Social Care professionals were allocated to work in ED determining suitability for; 1. Community services

“All professions dedicated resources on the Frail Elderly ward, ED and Day Hospital where possible in spite of a lack of staff for many months. The results of the impact (below), made by all professions, even if the measurement was for a short period of time, dramatically showed the enormity of the collective addition and quality improvement to patient care when dedicating resources in a united way.” Pharmacy Department Emergency Ward two week period snapshot The pharmacist focussed on the identified frail patient, reviewed on average 11.5 drugs per patient and determined per patient at least 2 drug related problems.

82 950

Drug supply required outsideof ward stock

1

Drug chart Problems per patient

2

Problems identified during medicines reconciliation per patient

3.5

Day Hospital over a six month period This new service sees the pharmacist working alongside the geriatricians undertaking a medicines use review of frail patients, saving an estimated 10 minutes of doctor patient clinic time and resolving on average 1.8 drug related issues per patient. Patients seen

387

No interventions made

696

Average intervention per patient

108


In patient Ward over a 6 month period

250

Figure 1: In patient Ward over a 6 month period

200 150

No. Drug related issued identified by pharmacist

100

No. drug related issues resolved

50 0

Nov – Dec 2015

Jan 2016

Feb-Mar 2016

Totals

ED Occupational Therapy Service Snapshot: 11th-22nd Jan 2016 100 Dieticians

Figure 2: ED Occupational Therapy Service Snapshot: 11th-22nd Jan 2016

Patient Numbers

Referrals from 87 90 Triaged by OT o FITT 80 o Consultants Admitted patients seen o Emergency Medicine Team by OT • 70 Integral member of an ED based MDT and clear pathway established BRATs OT Referrals o Limited delay between referral and assessment • 60 Patients referred, assessed and discharged from ED BRATs patients discharged home o Provided48 with written information & contact details 50 Outreach visits o Commenced on oral nutritional supplements if required completed o Offered follow up 40 Referrals to Day • Patients transferred to 31 ward 29 Hospital OT 30 o Early intervention for all patients o Commenced on nutrition care plan within short admission timeframe 20 o Appropriate nutritional supplements prescribed • Patients requiring follow up in Elderly Day Hospital 8 10 4 o Therapy to therapy referrals1 0 o Cohesive multidisciplinary Team approach Patient Type

Quarter 4 2014 2015

Patients 8 69

Dieticians Referrals from

Physiotherapy o FITT

Interventions 14 79

o Appropriate nutritional supplements prescribed

Occupational Therapy

• Early assessment of physical, cognitive and functional ability, • Patients requiring follow up in Speech and Language Therapy New Patients: Beaumont Physiotherapy service o Consultants allowing initiation of treatment Elderly Day Hospital Sept-Dec Referrals are taken from FITTeam and medical referrals. The service aims to provide the following: on appropriate pathway o Emergency Medicine Team assessmentto sotherapy early identification referrals of needs 700 o Prompt referral and same dayo Therapy • Rehabilitation o For those discharged home, ensure follow up by Primary care services – previously were not and collaborative • Integral 600 member of an ED discharge planning commences o Cohesive multidisciplinary based MDT and clear pathway 500 on day 1 Team approach established 400

o Limited 300 delay between referral and200 assessment 100 • Patients referred, assessed and discharged from ED 0

Overall COE service

o Provided 2014 with written 309 information & contact details 2015 587

o Commenced on oral nutritional supplements if required o Offered follow up • Patients transferred to ward o Early intervention for all patients o Commenced on nutrition care plan within short admission timeframe

Quarter 4 Patients Interventions 2014 8 14 2015 69 79 Speech and Language Therapy ED 85

• Referrals are taken from FIT 426 Team and medical referrals. The service aims to provide the following: o Prompt referral and same day assessment so early identification of needs o For those discharged home, ensure follow up by Primary care services – previously were not referred to PCCC

Awards Hospital Professional

2017

• Unique contribution from OT screening for and early management of: o Safety issues at home o Delirium and cognitive impairment o Pressure care risks Medical Social Work Day Hospital Referrals from the FITT, Medical teams and Community services yielded early identification of needs allowing either community service follow up via PCC, HCP PHN etc or the Day Hospital via therapy to therapy referrals.

Beaumont Hospital saw 34 less deaths in the first quarter of 2016 in those ages 74+. There were 36 less deaths in the whole emergency medical admission cohort but improvement is due to this 75+ age group. The next steps for the plan are currently underway with core ward model with MDT and associated pathway development alongside expansion of the day hospital services with new pathways and urgent access; rapid access to rehabilitation; earlier discharge from rehabilitation; expand links with community with development of new pathways to avoid the need to attend ED. Nuala added, “We are over the moon to receive this Award, which we see as magnificent recognition of am innovation we began this time last year. This was when allied health professional got together within our hospital including social work department, physiotherapy, speech and language therapy, occupational therapy, dietetics and pharmacy and pulled all our resources together in our services to the care of the elderly. “We met our elderly, the frail elderly in particular, at the hospital front door and focused all of our specialisms towards them to make their journey through the hospital the best we could. Our aim has been to give them an extremely good quality of life depending on their needs. We address their needs and ensure their hospital stay is as short as possible. Team Members Fiona Keoghan- Head of Clinical Services and Business Planning, responsible for delivering on the care of the elderly hospital improvement plan in the hospital. Nuala Doyle Head of Pharmacy Services Ann Healy - Speech and Language Therapy Manager Helen Heery Physiotherapy Manager Alison Enright Occupational Therapy Manager Paula O’Connor Dietician in Charge Manager Heather Hawthorne Social Work Manager All manager listed above were responsible for delivering on innovation and results of improvement within their professions.

Hospital Professional Awards 2017, Saturday September 16th, 2017, Clayton Hotel (Burlington) Dublin HPN • Professional Top100 - 2016


HPN Awards: Young Hospital Professional

Dearbhla's leadership skills lead to Young Professional Award Dearbhla Murphy, Clinical Pharmacist, Mater Misericodiae University Hospital

completed her M(Pharm) with the RCSI in 2013 during her intern placement in the MMUH and she is currently studying for her MSc in Clinical Pharmacy Practice with Robert Gordon University, having completed the Diploma component of this Masters programme. She is currently assessing areas for research to facilitate Masters completion. Dearbhla has been working as an Aseptic Compounding Pharmacist at the MMUH, a highly specialised role in a high risk environment and has many responsibilities including managing the ACU services, clinically verification of chemotherapy prescriptions and chemotherapy protocols development, governance and implementation. In recognition of her exceptional work standards, since May 2016, her responsibilities have expanded to include the provision of the Clinical Pharmacy service for the Oncology/Haematology in-patients. Dearbhla is also the cover pharmacist for Oncology/ Haematology Clinical Trials.

Dearbhla Murphy has been working within the specialty of oncology at the Mater Misericordiae University Hospital (MMUH) for the last two years. Positioned in the Pharmacy Department there, her ambition, drive and unfailing passion to enhance her field led to her being awarded the title of HPN Young

Professional Top100 - 2016 â&#x20AC;˘ HPN

Hospital Professional of the Year at the 2016 Hospital Professional Awards held last September. Dearbhla works half time as a Clinical Pharmacist alongside her role in the Aseptic Compounding Unit and is known throughout her department as a driven and hardworking individual who enjoys working as part of a team. She is

described enthusiastically by her colleagues as popular with staff and patients alike and dedicated to her role in oncology, always striving to improve the Oncology Pharmacy service for the better of her patients.

In July 2015, the MMUH introduced electronic prescribing for chemotherapy. Electronic prescribing has been identified as a key priority for the State in the National eHealth Strategy published in 2013. Last year, standards that will enable doctors to prescribe medication electronically to help reduce errors were published by the Health Information and Quality Authority (Hiqa).

Dearbhla graduated from Trinity College with a First Class Honours Pharmacy degree in 2012. She

Within hospitals, advocates argue that electronic systems can help reduce the errors that


Dearbhla has demonstrated exceptional leadership in her roles. Her leadership is aligned with being an active part of the team, communicating and respecting others’ opinions, listening, and recognising opportunities for interventions and service development. inevitably arise with handwritten prescriptions by making the name of medications more legible, setting limits for dosage, and flagging potential negative interactions. In Ireland electronic prescribing remains the exception rather than the rule. The Hospital Pharmacists Association of Ireland (HPAI) recently urged the Government to make more funding available for IT systems in hospital pharmacies, which would allow for electronic prescribing to be implemented on a widespread basis. Following the implementation of this new software Dearbhla designed and conducted a research study investigating the rate of prescribing errors and omissions using handwritten versus electronic prescriptions. She was awarded an Education Bursary for this work at the 2016 Irish Society of Medical Oncology Meeting. Dearbhla was also selected to present her project at the 2016 HPAI annual conference. The association’s annual conference heard about the clinical benefits such systems can bring when they are properly installed and supported. One presentation focused on the introduction of an electronic software package for chemotherapy and haematology drugs in the Mater Hospital Pharmacy in July 2015, which led to prescribing errors being reduced by more than 50%. At least one error was found in 29.4% of handwritten prescriptions, compared with 13.7% of electronic prescriptions using the Cato system, an integrated software system.

In 2015, she presented a case study at the HPAI annual conference of dosing chemotherapy in obese patients, an emerging area of clinical research. This research poster of this work was presented at American Society of Health-System Pharmacist (ASHP) Conference, 2015. In 2013, she developed a cross-reference list of potentially photosensitising drugs for use by the Dermatology Department prior to the administration of ultraviolet light therapy. The resultant poster presentation was highly commended at the 2013 HPAI annual conference. Dearbhla has demonstrated exceptional leadership in her roles. Her leadership is aligned with being an active part of the team, communicating and respecting others’ opinions, listening, and recognising opportunities for interventions and service development. An example of this is her attendance at the Oncology multidisciplinary team meetings. During these meetings she advises the Consultants on treatment doses, patient progress, toxicity management and drug interactions. Her role as a Clinical Pharmacist involves daily interaction with the multidisciplinary team to provide a quality Clinical Pharmacy service to patients in the MMUH.

In July 2015, the MMUH introduced electronic prescribing for chemotherapy. She played a vital role in the execution of this successful project. She was responsible for producing and verifying local chemotherapy protocols prior to the system going live. This work required both in-depth clinical oncology knowledge but also information technology skills. During this process Dearbhla brought about many innovative ideas to the system which now support nurses, doctors and pharmacists. Dearbhla continues to work with Oncology/Haematology consultants to update and write new chemotherapy protocols as required.

Being part of the Oncology team Dearbhla prepares and delivers education sessions to the Oncology medical team as part of their weekly journal club.

Following the electronic system going live in the hospital Dearbhla provided on-going training and assistance to medical and nursing staff on using the system. Dearbhla’s clinical pharmacy contribution at ward rounds and comprehensive knowledge of the new electronic prescribing system and chemotherapy protocols means that Dearbhla is a highly valued member of the Oncology/Haematology multidisciplinary team.

Specialising in Oncology soon after graduating she was tasked

A further major change for the aseptics services at the MMUH

Awards Hospital Professional

with managing a very busy ACU early within her career. In that time the ACU in the MMUH has seen a significant amount of change during which Dearbhla has exhibited initiative and leadership by being proactive and problem solving and deriving satisfaction from the implementation of change. Examples are detailed below:

2017

this year was the relocation of the ACU to a new state of the art facility. Dearbhla was instrumental in the organisation and planning of the move, playing a key support role to the ACU manager. Dearbhla’s innovative ideas and organisation skills helped ensure the success of this move. Dearbhla provides a clinical pharmacy service to the Oncology/ Haematology ward. Using her training in the ACU alongside her clinical experience Dearbhla has met the challenge of this new role. Dearbhla is also the cover pharmacist for Oncology/ Haematology Clinical Trials. This role requires close attention to detail and good organisation skills. Dearbhla has completed a number of research projects to date. Through these projects Dearbhla has shown her enthusiasm to improve Irish hospital pharmacy practice. Dearbhla is passionate about research and is very excited about her upcoming MSc project. Dearbhla is involved in training pharmacists, technicians and students in the ACU. A task she takes to easily with her excellent leadership and communication skills. Dearbhla loves her work in the MMUH. Dearbhla is very enthusiastic and dedicated to her role in Oncology. Her enthusiasm to be part of the ACU and Oncology/Haematology teams is evident and it is already apparent that Dearbhla is driving not only the progression of her career but of the pharmacy profession. Jennifer Brown, Pharmacy Manager at the hospital says, “Most people aren’t typically thought of as leaders in the workplace early in their careers, and it is often difficult for young professionals to assume a leadership role. In Dearbhla’s case, the right attitude, hard work and a desire to learn have demonstrated her leadership capabilities and there is no doubt that Dearbhla will continue to develop pharmacy services, both within her speciality and beyond throughout her career.” Dearbhla Murphy, Clinical Pharmacist with the Mater Misericordiae University Hospital, won the HPN Young Hospital Professional of the Year Award 2016.

Hospital Professional Awards 2017, Saturday September 16th, 2017, Clayton Hotel (Burlington) Dublin HPN • Professional Top100 - 2016


HPN Awards: MSD Antimicrobial Pharmacist

Marie continues to drive the role of Pharmacy in Antimicrobials Marie Philbin, Antimicrobial Pharmacist, Midland Regional Hospital Tullamore

The World Health Organisation defines antimicrobial resistance (AMR) as “the resistance of a microorganism to an antimicrobial medicine to which it was originally sensitive. Resistant organisms (including bacteria, fungi, viruses and some parasites) are able to withstand attack by antimicrobial medicines, such as antibiotics, antifungals, antivirals, and antimalarials, which means that standard treatments become ineffective and infections persist increasing the risk of spread to others.” Leading the way for Antimicrobial Pharmacists in Ireland has been Marie Philbin, who was awarded the MSD Antimicrobial Pharmacist of the Year Award for 2016 at the Hospital Professional Awards held in September. Marie Philbin has been the Antimicrobial Pharmacist in Midland Regional Hospital Tullamore (MRHT) since 2004 and is the longest serving in this role in Ireland. Marie’s initial work in MRHT demonstrated significant cost savings, a trend from broad spectrum to narrow spectrum agents and an accompanying reduction in Clostridium difficile

Professional Top100 - 2016 • HPN

infection. This work was the stimulus for the HSE creation of 20 Antimicrobial Pharmacist positions in hospitals around the country. This initial work also won Marie the Servier award bursary of ¤3,500 at the HPAI annual conference in 2005. Antimicrobial resistance poses a major threat to the future of healthcare with significant clinical, public health and economic implications; resistant infections claim at least 25,000 lives each year across Europe. The problem is undoubtedly increasing. In 15 EU countries, >10% of bloodstream Staphylococcus aureus infections are caused by methicillin-resistant Staphylococcus aureus (MRSA) and several of these countries have resistance rates close t o 50%. The use and inappropriate use of antimicrobial drugs is a recognised driver for resistance and reductions in resistance has been shown to coincide with shifts in prescribing practice. Until 2007, for example, the UK saw major increases in both cephalosporin and quinolone resistance amongst Escherichia

coli and Klebsiella spp, however since 2007 resistance to these have decreased/plateaued (LabBase and BSAC data). This fall in resistance coincides with a large reduction in cephalosporin and quinolone use due to national antimicrobial stewardship guidance, which was introduced to reduce Clostridium difficile infections nationally. Over the years, the role of pharmacists in leading AMS programmes has expanded, and interventional studies have shown the positive impact of having pharmacists as part of antimicrobial stewardship teams. Marie’s work in MRHT initially involved audit and feedback, education and bedside patient review. Over the years her work has also encompassed guideline development, expenditure and consumption monitoring, quality improvement projects on surgical prophylaxis, implementation of restriction policies, creation of a designated antimicrobial section in the medication chart. Marie is seen in the hospital as an expert in her field and is held in high regard, she is regularly consulted by Consultant Clinicians, is a key member of both the

Infection Control Team and the Antimicrobial Stewardship Team. Marie is the Hospital Lead for the management of OPAT which has proven hugely beneficial to the hospital in assisting in reducing bed pressures. While Marie is the Antimicrobial Pharmacist she has also taken the successful lead on various other projects within the Pharmacy Department including LEAN, Accreditation and new medication kardexes for the hospital. Marie is dedicated to pursing her formal educational qualifications and has obtained an MSc in Clinical Pharmacy with a thesis looking at the impact of the Antimicrobial Pharmacist on antimicrobial consumption data and a Postgraduate Diploma in Healthcare Management. She also successfully completed the HSE 10-day “Management Development Programme”, the US IHI Basic curriculum in Quality Improvement, Leadership and Patient Safety and the ISMP Medication Safety course. Marie was one of the founding members of the Irish Antimicrobial Pharmacist Group in 2008 and has been Chair of the group since.


Marie Philbin, Antimicrobial Pharmacist, Midland Regional Hospital Tullamore

Marie has given huge commitment to developing the role of the Antimicrobial Pharmacist nationally and striving to achieve a vision that the Antimicrobial Pharmacists in Ireland are an invaluable and highly sought after resource. There is a membership of approximately 40 pharmacists and this is continuously growing. In her role as Chair she represents the IAPG on the National HCAI/AMR Clinical Advisory Group, the National Antimicrobial Stewardship in Hospitals committee. Marie has been central to the representation and involvement of Antimicrobial Pharmacists in many other key infection related national committees and working groups. As Chair she drives and co-ordinates the many work streams (executive committee, education subcommittee etc.) of IAPG in achieving their mission and functions. The benefits of IAPG working collectively has been demonstrated by many collaborative projects such as the Annual National Point Prevalence Study, contributions to National

Guidelines, National Antimicrobial Consumption data, Gentamicin Quality Improvement Project etc. clearly evidenced in their detailed and impressive annual reports. When dealing with Senior Management finance is one of the focal areas of interest. To this end in 2009 Marie and an IAPG colleague produced a report for Dr Kevin Kelleher in the HSE to support the replacement of Antimicrobial Pharmacist positions for extended leave. This report demonstrated that for every ¤1 investment in Pharmacist salary there is a ¤3 saving. Over the years Marie has hosted Antimicrobial Pharmacists new to the role in MRHT and frequently provides guidance, assistance and advice to other Antimicrobial Pharmacists and National Leads in the area of infection. Her interest in education extends to the supervision of various staff

members within the Pharmacy Department; Basic Grade Technician completing Clinical Diploma with University of Derby, Intern Pharmacist in 2013, Pharmacists completing the MSc with Trinity College Dublin. She coordinated our weekly in-house voluntary Pharmacist CPD session from Summer 2007 to 2015. Also as part of Marie’s dedication to raising standards and education she along with Professor Tom Rogers of TCD and St James Hospital arranged an intensive education programme for Antimicrobial Pharmacists funded by the HSE. The Antimicrobial Pharmacists had the benefit of being educated by both National & International experts in various areas of antimicrobials & infectious diseases. Marie was also central to the establishment of bi-annual IAPG study days supported by the HSE. Marie is willing to pursue issues that might seem futile on first glance. Her liaison with the HPRA regarding HIV post exposure prophylaxis packs meant their supply from the UK was re-instated. And it was this persistence that resulted in the HSE funding of the Intensive course for Antimicrobials back in 2010 when funding for such projects was almost non-existent. Marie has built strong external relationships by attending and networking at conferences and meetings attended by Infectious Disease Physicians, Microbiologists and Infection Control Nurses. She has presented to all of these professions at their own meetings or at collective National or International meetings: European Antibiotic Awareness Day, IDSI 2011, Infection Control Nurses 2014, FIS 2008 in Cardiff, UKCPA 2008. This work & networking has enhanced the profile of the IAPG among other professional infection-related groups. Overall Marie is a very dedicated and hard-working Pharmacist. She works to a very high standard. She has strong interpersonal skills and has given huge commitment to developing the role of the Antimicrobial Pharmacist nationally and striving to achieve a vision that the Antimicrobial Pharmacists

in Ireland are an invaluable and highly sought after resource. Pharmacists have been shown to have a key role in AMS teams, particularly within secondary care. Specialist roles have highlighted the importance and impact of the specialist role to improve prescribing and patient outcomes particularly within inpatient and OPAT settings. In the future, pharmacists’ roles may be increased to prescribing of antibiotics and further involvement in outpatient clinics. Non-specialist pharmacists in the hospital sector have daily opportunities to impact on individual patient care by monitoring antibiotic use and adherence to guidelines, ensuring correct doses, for example, through therapeutic drug monitoring and appropriate antibiotic review, such as encouraging prompt IV to oral switch where appropriate. In the community sector there are few specialist antimicrobial pharmacists and very limited publications on the impact of pharmacists on AMS, despite 79% antimicrobial prescribing occurring in this sector. “I am extremely delighted to be the recipient of this Award for 2016. This is the first year of this Award category, it is fantastic to see this category is now a part of the Awards in general and so a huge thank you to Hospital Professional News and MSD for that recognition. It is a great tribute to the work of Antimicrobial Pharmacists across Ireland. “I was one of the first Antimicrobial Pharmacist positions to be established in Ireland and on the back of my original work came the creation of twenty antimicrobial posts in the country. From then, year on year there has been the creation of even more posts, recently within the Maternity Hospital here. “Our work hinges on the key multidisciplinary team which is the infection control team and the pharmacy department itself. We would not be able to do what we do and achieve what we achieve without the participation of the Clinical Pharmacists on the wards.”

Sponsors of the MSD Antimicrobial Pharmacist of the Year 2016 Hospital Professional Awards HPN • Professional Top100 - 2016


HPN Awards: Actavis Innovation in Aseptics

Making use of Lean in an Aseptic Unit Back row: Bernadette Quinn, Pharmacy Technician, Rita Sweeney Senior Pharmacy Technician, Joanne Nally Snr Pharmacist, Marie O Grady Senior Pharmacy Technician. Front row: Anne O Flynn Pharmacy Technician, Olivia Flynn Chief II Pharmacist, Marie Godley Senior Pharmacist* Missing from photo Michelle English Senior Pharmacy Clinical Trials, Nora McSweeney Senior Pharmacy Technician, Sheila Walsh Pharmacy Technician

becoming a vital component of Pharmacy practice. Many health care professionals recognise that, for some specific patient populations, there is a growing need to compound certain medications because they are not available through conventional manufacturing methods. Many compounding pharmacies specialise in compounding customized medications in various dosage forms that can be tailored to meet a patient's individual need.

In the early days of pharmacy, compounding medications was an integral part of a pharmacist's daily duties. Medications were prepared in the Pharmacy from stock bottles of ingredients that lined the shelves. During the 1930s and 1940s, about 60% of prescriptions were compounded by Pharmacists.

Professional Top100 - 2016 â&#x20AC;˘ HPN

The role of the pharmacist has changed over the years due to advances in the field of Pharmacy and the emergence of new drug-manufacturing technology. In many ways, the role of the pharmacist progressed from being the "medication preparer" to being the "dispenser of manufactured medications," and this change

greatly decreased the need for Pharmacy compounding. As the profession of Pharmacy evolved over the years, so did the role of the pharmacist in addressing and meeting the needs of patients. Today, however, compounding pharmacies have begun to flourish and are once again

The Cancer Centre at University Hospital Limerick is one of eight designated centres of excellence for cancer treatment in the country. The Aseptic Compounding Unit (ACU) at UHL manufactures individually tailored chemotherapy and biological preparations for patients attending UHL for cancer treatment and is fully equipped with modern isolator technology in a clean room environment. The unit is staffed by qualified and trained Pharmacists and Pharmacy technicians. The objectives of the ACU are to continually provide a safe, efficient and high quality service to their patients and other service users.


At the University Hospital Limerick, Cancer Services, workload is continually increasing, this manifests as an increase in the number of chemotherapy prescriptions to be prepared in Pharmacy. Chief II Pharmacist Olivia Flynn explains, “We try to ensure work is done as quickly and as efficiently as possible, we do not want to overlook the importance of continually providing the highest of standards in safety and quality control in our manufacturing processes. It was important that we implement a plan to help elevate some of the pressures of these increased demands on our service. “One of our team members had just completed a course in Lean Management systems, so we discussed this principle and decided to embrace the principles of lean management in our A.C.U. With this system we reviewed every step in our processes to determine if/where any time savings could be made to ensure we provide the most efficient pharmacy service possible.” Lean process improvement is an industry-wide initiative to achieve operational excellence. The lean process approach facilitates improvement of process efficiency and quality while delivering faster service and cost reductions. Originating with the Toyota Production System (TPS) soon after World War II, the concepts of lean implementation are no longer confined to manufacturing. They have been successfully applied to service and administrative processes. Many excellent reference resources on the subject provide the progressive Pharmacy Executive with good background information. The industry-wide acceptance of Lean Principles has given rise to their expanded use outside of manufacturing and directly into healthcare applications. This thinking has led to the desire in some facilities to integrate Lean concepts with available automation as a way to advance

Olivia Flynn Chief II Pharmacist

safety in pharmacy practice especially in the area of compounded sterile preparations (CSPs). Following a team brainstorming session a list was made of the process where staff felt they could improve efficiencies, revising or cutting out steps that would not create a more efficient and effective use of Pharmacy time. This list was prioritised and the first priority process identified was • Organisation of patient chemotherapy trays for compounding The group discussed what they believed was the correct approach to organise the trays, a process map was created which gave a clearer understanding of all the activities involved, who was responsible for what duties and what steps were not creating value, thus wasting time. All ideas were written down on a white board and from that we devised a lean plan which effectively saved valuable Pharmacy time. “We identified that there had been a lot of time wasted on the morning of treatment looking for trays that either had no prescriptions or no tray was prepared in error,” Olivia continues. “We devised a standardised system that the trays were taken out the evening before and the priority treatments were put in first along with any treatment that could be made in advance. “The patient diary would then be then denoted with a marking system that everyone could understand, even rotational staff and they could follow up on any discrepancies first thing in the morning. All prescriptions

were endorsed by technician at the dispensing stage (as trays are compiled up to a week in advance of treatment) so if a tray was not assembled, one could be done straight away. The work flow and rate of production time increased within the unit due to time saving. These efficiencies added value to pharmacist and technician duties which further allowed us to accommodate an increased number of patient doses. “Utilising the lean process system has been our new innovation and has resulted in significant time saving to our work in the A.C.U and hope to integrate these principles into all our processes going forward. We feel this process fits the criteria for this award as it was a new innovation that the whole team embraced, fostering good team spirit resulting in a more efficient service to our patients and other service users which is always our primary aim.” Olivia Flynn adds, “By improving our efficiency it is possible to reduce the time a patient spends waiting on the Oncology day ward for their chemotherapy to arrive from Pharmacy.

Improved efficiency can also put a little extra capacity into the compounding workload, which may allow patients to be treated a few days earlier than otherwise.” Looking to the future she adds, “Activity, as measured by the number of doses of chemotherapy prepared, continues to increase on an on-going basis. There are more anticancer drugs becoming available, and some patients may get multiple lines of treatment, which all contributes to increased workload for pharmacy and the Oncology day ward. There will be an ongoing requirement for additional trained staff. “We will continue working on our lean processing. We have a prioritised list of topics that require lean processing principles to be applied. “We are interested in extending the role of the Pharmacy Technician within the unit, and are hoping for our Senior Technicians to pursue technician accreditation, whereby they will be able to take over certain duties previously only performed by a pharmacist.”

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CPD 27: Hepatitis C Continuing Professional Development

CPD

AUTHORS - Matthew Hickman1, Daniela De Angelis2, Peter Vickerman1,Sharon Hutchinson3, and Natasha Martin1,4 1. School of Social and Community Medicine, University of Bristol, UK. 2. MRC Biostatistics Unit, University of Cambridge & Public Health England, UK. 3. Glasgow Caledonian University & Health Protection Scotland, UK. 4. Division of Global Public Health, University of California San Diego, USA

1. REFLECT - Before reading this module, consider the following: Will this clinical area be relevant to my practice?

3. PLAN - If I have identified a knowledge gap - will this article satisfy those needs or will more reading be required?

2. IDENTIFY - If the answer is no, I may still be interested in the area but the article may not contribute towards my continuing professional development (CPD). If the answer is yes, I should identify any knowledge gaps in the clinical area.

4. EVALUATE - Did this article meet my learning needs - and how has my practise changed as a result? Have I identified further learning needs?

60 Second Summary There is growing evidence that traditional primary prevention such as opiate substitution treatment (OST) and needle and syringe programmes (NSP) can reduce HCV transmission. However, epidemiological models and observational data (which report persistently high levels of HCV among PWID despite high intervention coverage) suggest that these interventions are unlikely to achieve substantial reductions in HCV transmission and prevalence among PWID. The prime purpose of HCV treatment is viral clearance from the individual patient which reduces the risk of progression to more severe liver disease and premature HCV related mortality. International guidelines in 2014 recommended treatment prioritisation for moderate to severe liver disease stages (F2-F4) due to the individual's immediate risk of liver disease progression. The issue of how to best assess impact/measure treatment as prevention outcome (i.e. HCV prevalence and incidence in PWID in the community) remains unresolved. Several alternative outcomes have been proposed to infer treatment as prevention impact. Evidence from the HIV Prevention Trial Network 052 (HPTN 052) trial (47, 48) on the ability of ART to substantially reduce HIV transmission in stable HIV serodiscordant couples, has stimulated the development of models (see (49) for a review) suggesting a variety of benefits at population level from an expanded ART programme, including elimination of HIV within a short time scale.

53

5. WHAT NEXT - At this time you may like to record your learning for future use or

assessment. Follow the 4 previous steps, log and record your findings. Published by HPN, sponsored by MSD. Copies can be downloaded from www.irishpharmacytraining.ie Disclaimer: All material published is copyright, no part of this can be used in any other publication without permission of the publishers and author. MSD has no editorial oversight of the CPD programmes included in these modules.

HCV Treatment as Prevention in People Who Inject Drugs – testing the evidence In many European settings, over 80% of HCV infection was acquired through injecting drug use(1, 2). The prevalence of HCV among PWID is generally high but heterogeneous, ranging from 20 to 80% in individual countries and sites(3). There is growing evidence that traditional primary prevention such as opiate substitution treatment (OST) and needle and syringe programmes (NSP) can reduce HCV transmission(4-6). For example, recent evidence from Vancouver, Canada(7), Australia(8) and San Francisco in the USA(9), report that OST can reduce the risk of HCV transmission by 50-80%. However, epidemiological models and observational data (which report persistently high levels of HCV among PWID despite high intervention coverage) suggest that these interventions are unlikely to achieve substantial reductions in HCV transmission and prevalence among PWID. A recent analysis of the Amsterdam IDU cohort(7) suggested a large proportion of the decline in HIV and HCV may have been due to factors other than the scale of harm reduction, and a modelling study in the UK suggested that further harm reduction scale-up may only achieve modest reductions in prevalence and require several decades(8). Therefore, there is considerable interest in the role of HCV treatment as prevention to enhance other primary interventions and drive HCV transmission and HCV chronic prevalence to negligible levels (i.e. towards elimination). The availability of new highly effective, tolerable,

short-course interferon free direct acting antiviral therapies (IFN-free DAAs)(9-13) has added further optimism that HCV treatment could be used for prevention(14) as well as reduce morbidity from liver disease(15). The prime purpose of HCV treatment is viral clearance from the individual patient which reduces the risk of progression to more severe liver disease and premature HCV related mortality. International guidelines in 2014 recommended treatment prioritisation for moderate to severe liver disease stages (F2-F4) due to the individual's immediate risk of liver disease progression(16). Updated 2015 European guidelines now also recommend providing treatment for people at risk of transmission – such as PWID – irrespective of fibrosis stage(17). Guidelines in the US similarly recommend treatment for people at risk of transmission, but do not specify their ‘priority ranking’, in contrast to other groups which are assigned the ‘highest priority’ (such as F3-F4) and ‘high priority’ (such as F2)(18). We consider the evidence for HCV treatment as prevention among PWID, including issues of cost-effectiveness and prioritization, and discuss what needs to be addressed in evaluating HCV treatment as prevention in PWID populations. Empirical evidence vs. modelling evidence We are unaware of any trials or other evaluation studies that have tested whether

Continuous Professional Development Modules are sponsored by MSD MSD has no editorial oversight of the CPD programmes included in these modules.


54

CPD 27: Hepatitis C

HCV treatment can reduce HCV chronic prevalence and transmission in PWID populations. The evidence for the potential of HCV treatment among PWID derives from theoretical modelling studies(19-32), largely assessing the impact of older interferon based treatments and mostly in high-income settings. Modelling studies projecting the impact of HCV treatment among PWID require the use of dynamic transmission models which mechanistically model transmission such that changes in prevalence (for example through scale-up of treatment) are linked to an individual's risk of acquiring infection, and therefore incidence. These models therefore account for both the risk of re-infection and the reduction of HCV risk through averting future/secondary infections(33). These dynamic modelling studies have shown that modest levels of treatment with both traditional interferon based treatments (with lower cure rates), as well as new DAAs, could be effective and reduce HCV chronic prevalence among PWID in most settings – especially when chronic HCV is 40% or below in the PWID population(31)(32). For example, substantial reductions in HCV chronic prevalence among PWID have been projected in UK and France in the future by switching to DAAs and scaling-up to treatment rates achieved in some sites(34) (21) . There is a prevention benefit to HCV treatment if more PWID have avoided HCV infection than became re-infected, and if more health benefit is gained (in terms of reducing End Stage Liver Disease and HCV related deaths) through reducing HCV transmission than are lost through

people becoming re-infected. The costeffectiveness of treating PWID is driven by the prevention benefit as shown with interferon(35) and in a study of the prioritisation of new DAA treatments(36). Without the dynamic element estimating the “prevention benefit” then the costeffectiveness of HCV treatment and its prioritisation is determined by disease severity(37) with people with severe or moderate disease treated preferentially over people with mild disease. The key empirical evidence required to underpin these models is to show that HCV treatment for those at risk reduces HCV transmission. However, no epidemiological evidence has yet emerged linking HCV treatment to changes in HCV incidence or prevalence in PWID. One reason for the lack of epidemiological evidence is that studies of HCV treatment rates among PWID estimate that treatment rates tend to be too low to reduce the incidence of End Stage Liver Disease (ESLD) and HCV related mortality - let alone to reduce HCV transmission in key populations such as PWID(2, 38, 39). Alternative outcomes: SVR and Reinfection rates The issue of how to best assess impact/ measure treatment as prevention outcome (i.e. HCV prevalence and incidence in PWID in the community) remains unresolved. Several alternative outcomes have been proposed to infer treatment as prevention impact. Trials of the effectiveness of HCV treatment report sustained viral response

(SVR) as the outcome. First and second phase clinical trials tend to exclude PWID. There is good evidence that SVR outcomes in PWID, especially if patients are in opiate substitution therapy (OST), are similar to clinical trials(40, 41), and new evidence no doubt will emerge showing that PWID also can achieve high rates of SVR when treated with new DAAs. For example, some new clinical trials are investigating treatment of PWID on OST. Modelling evidence also has shown that HCV treatment with IFN/RBV is effective and cost-effective even if SVR rates are lower than for other patient groups (because of the potential prevention benefit)(35, 42). Recent modelling work has indicated that early DAA treatment at a moderate stage for PWID is costeffective in the UK, and treatment at a mild stage for PWID is cost-effective and should be prioritized in settings with chronic prevalence <60% due to primary prevention benefits. However, no studies have looked at the cost-effectiveness of HCV treatment for PWID in low or middle income country settings, and existing studies are not based on realworld DAA SVR outcomes among PWID. Nonetheless, measuring SVR is not an indication alone of the impact of HCV treatment on HCV transmission risk. Fewer studies have measured HCV reinfection rates which in some cases have been reported as low (<5% per year) (40, 43) which over time could be a cause for concern(44). In model projections reinfection rates are assumed to be similar to primary infection rates (and depending on level of injecting risk and exposure to other interventions such as OST and high coverage NSP). No empirical studies (or modelling studies) have yet compared reinfection rates in PWID with community HCV incidence in order to determine under what circumstances re-infection rates can be used as proxy measures/ unbiased estimates of the impact of HCV treatment on transmission rates in the population. The HIV analogy The problem of evaluating effectiveness of public health interventions has been recurrent in the field of HIV for some years. The discussion started with the need to assess the impact of initiatives to change sexual behaviours in developing countries (e.g. see(45)) and the debate has more recently extended to the consideration of ART as prevention, namely as a means of reducing transmission and eventually eliminating HIV(46). Evidence from the HIV Prevention Trial Network 052 (HPTN 052) trial(47, 48) on the ability of ART to substantially reduce HIV transmission in stable HIV serodiscordant couples, has stimulated the development of models (see(49) for a review) suggesting a variety

Continuous Professional Development Modules are sponsored by MSD MSD has no editorial oversight of the CPD programmes included in these modules.


55 of benefits at population level from an expanded ART programme, including elimination of HIV within a short time scale. The modelling led to several treatment as prevention trials at the community level- including interventions in Botswana and the POPART intervention(50) in Zambia and South Africa(51). POPART involves a combination of increased HIV screening, immediate ART (irrespective of baseline CD4-count) and other primary interventions (such as male circumcision, providing condoms and early treatment of other STI). The trial is currently being carried out in 21 study clusters with the main outcome, HIV incidence, measured over the study period on a population cohort of 2,500 individuals randomly selected from each clusters(52). However, such interventions concern a generalised epidemic in developing countries and although, modelling results suggest that early treatment of HIV in PWID would reduce transmission(53), no analogous evaluation project among PWID is being undertaken. Ecological correlations have been reported between community measures of HIV viral load and HIV incidence in Vancouver and interpreted as evidence that ART could decrease HIV transmission amongst PWID(54). However, concurrent decreases in HCV incidence suggest that injecting risk may have also decreased, which could represent a further explanation, other than the scale-up of ART, for the decrease in HIV incidence). There are important distinctions also between HIV and HCV treatment as prevention. HCV treatment has the distinct advantage over HIV treatment that duration of treatment is short and highly efficacious. However, unlike in the HIV generalised epidemic in Africa, HCV transmission in developed countries is mainly driven by the risk in PWID and treatment as prevention outcomes among this hidden population maybe more difficult to measure. PWID prevalence (and HCV treatment rates) The size of the PWID population constitutes a critical ingredient for “treatment as prevention” trials as the estimation of the number of PWID with chronic HCV and number of HCV treatments required to reduce HCV transmission to specific levels depends on its knowledge. Sample size calculations and preparatory evaluation work need to characterise the population at risk – which is no easy task as highlighted by Global Burden of Disease estimates of injecting/ drug related harm(55, 56). The PWID population is a “mixture population” of people at risk of acquiring

and transmitting infection, encompassing people who currently inject, and people who are in treatment or prison or have recently ceased injecting and are at high risk of relapse. The burden of HCV among PWID in prison and opportunities for prevention is considered in more detail elsewhere (57) (58). Existing PWID prevalence estimates rarely capture the whole population at risk. These estimates typically refer to active injectors (often defined as injected within the last month or 6 months) and exclude those who have temporarily ceased injecting, leading to a potential underestimation. Available estimates are also notoriously uncertain(34, 59) , often depending on the methodology used to derive them. PWID estimates for many countries and cities in Europe and elsewhere are out of date, missing, or inconsistent. For instance, in Scotland the estimated number of currently active PWID for has varied from 19,000 to 27,000(60); and the number of PWID in England varies from 130,000 to 200,000(1, 61, 62) . Chronic HCV prevalence and incidence The incidence and prevalence of HCV among PWID, a key outcome in any treatment as prevention trial, also is a composite measure – from PWID in and out of specialist drug treatment, in regular or infrequent contact with needle and syringe programmes (NSP), in and out of stable accommodation and in and out of prison. Routine voluntary HCV testing and public health surveillance systems necessarily only cover very specific subgroups that provide a multiplicity of pieces of information which if simply

aggregated together are unlikely to provide an unbiased estimate of HCV transmission(62). Community surveys of PWID, even those recruited through novel recruitment techniques also have been shown to be potentially biased, especially if sampling only a small proportion of the total PWID population(63). In these circumstances, linking and combining the various sources of data while accounting for the biases can be a viable way of producing meaningful estimates. An example of the type of linkage and data synthesis is the recent work conducted in Scotland where combining data from the Scottish drugs misuse database; the HCV diagnoses register(64); the NESI needle exchange surveillance scheme(65); and a capture-recapture study on a recently infected population(66), it has been possible, through a Bayesian evidence synthesis, to derive estimates of HCV (antibody) prevalence in PWID by agegroup, gender in Greater Glasgow & Clyde and the Rest of Scotland(67). A similar exercise may need to be undertaken in small geographical areas to generate the outcome measures for an evaluation of HCV treatment as prevention. Heterogeneity and Treatment Uptake It is known that there are heterogeneities in injecting and transmission risk and treatment uptake among PWID. High risk PWID may be more likely to transmit HCV and less likely to enter HCV treatment than low risk PWID. So as treatment is scaled-up will the intervention effect be compromised / reduced by selection bias? Some models and future trials have

Continuous Professional Development Modules are sponsored by MSD MSD has no editorial oversight of the CPD programmes included in these modules.


56

CPD 27: Hepatitis C such as the UK and USA, HCV treatment of PWID is cost-effective and could be more cost-effective than treating other patient groups at the same HCV disease stage who do not have an ongoing transmission risk. The impact and costeffectiveness of HVC treatment for PWID is driven by the potential “prevention benefit” of treating PWID. However, there is no direct empirical evidence from trials or observational studies that test the model projections and “prevention benefit” hypothesis. In part this is because of uncertainty in the evidence base but also because PWID HCV treatment rates historically in most sites have been low, and any scale-up and switch to the new DAA has not yet occurred.

considered the impact of delivering treatment through PWID networks in order potentially to maximize treatment as prevention benefits and reduce the number of treatments required to generate an effect(27, 29, 30). These modelling exercises suggest that a “treat your friends” strategy i.e. treating contacts of an infected case could have a greater impact than treating PWID randomly. Further, other modelling analyses assessing whether there is differential impact if HCV treatments are targeted to low or high risk or only to those on OST have generated inconsistent findings(22, 28, 31, 68) due to assumptions surrounding movement between high and low risk states– with some studies concluding that low risk PWID should be targeted in settings where chronic HCV prevalence may be high(28, 31), a further study suggesting that high risk PWID should be targeted(24), and others concluding that if there is movement between high and low risk then targeting is unlikely to make a difference on impact(68). Part of the problem and difficulty in determining optimal treatment targeting is because of uncertainty over the life course trajectory of injecting (such as the duration of injecting drug use until final cessation, timings of periods in and out of injection, and the time that PWID may stay in or out of a high risk period). Opiate/ PWID cohort studies emphasise opiate dependence is a chronic relapsing problem – whereas information derived from ex-PWID and population surveys suggest that illicit drug use has high rates

of remission (supporting an hypothesis that that people “mature” out of drug use) (22, 68-75). One modelling study suggests that HCV treatment will have a greater prevention impact in PWID populations with prolonged durations of injecting – whereas other primary prevention (OST and NSP) strategies are likely to have a greater impact in PWID populations with shorter average injecting durations(42). HCV treatment also may act synergistically with OST and NSP, which if increased or decreased over time could either enhance or reduce the impact of HCV treatment on HCV transmission outcomes(42). No evaluation of HCV treatment as prevention will be able to resolve uncertainties over the natural history of opiate dependence and injecting drug use – but it will be important that studies follow-up PWID treated for HCV and seek to characterise the PWID population in which the intervention and outcomes are being measured. Moreover, whether HCV treatment is targeted or delivered through PWID networks, the ultimate arbiter and key outcome will remain HCV prevalence and incidence among PWID.

This means there is a window of opportunity to conduct evaluations of HCV treatment as prevention – as is being undertaken in the HIV field. However, there will be a need (and an opportunity) also to resolve some of the underlying and prevailing issues surrounding measuring the prevalence of PWID and obtaining unbiased estimates of the prevalence and incidence of HCV among PWID in order to test and provide the empirical evidence for HCV treatment as prevention.

Key points • Scaling up HCV treatment is an essential component to prevention of HCV transmission among people who inject drugs (PWID). • There is strong theoretical evidence from modelling studies that treating PWID will be effective and cost-effective in reducing HCV transmission. • However, there is an absence of any direct evidence from epidemiological studies or trials in support of the “HCV treatment as prevention” hypothesis.

Conclusions There is good theoretical evidence from dynamic models that HCV treatment could reduce HCV transmission among PWID – in support of the recent change in clinical recommendations that HCV treatment should be provided to PWID irrespective of severity of liver disease. It is likely also that in high-income settings

• Future evaluations will need to resolve some problems with measuring outcomes in PWID populations.

Refences on Request.

Continuous Professional Development Modules are sponsored by MSD MSD has no editorial oversight of the CPD programmes included in these modules.


HPN Awards: Hospital Specialist 2016

Sarah shows Specialist research in Opthalmology Sarah Molony is the Deputy Clinical Pharmacy Service Manager in the Pharmacy department in the Mater Misericordiae University Hospital (MMUH) in Dublin. The Pharmacy Department in MMUH is a large, dynamic department,which embraces technology. Sarah has worked as a Clinical Pharmacist there since March 2012 having completed the Msc in Hospital Pharmacy from Trinity College Dublin. Sarah has worked as the emergency department and ophthalmology Pharmacist since January 2015. The MMUH is a tertiary care ophthalmology centre which treats complicated ophthalmological conditions. Her work within this area led Sarah to being awarded the 2016 HPN Hospital Specialist of the Year Award at the Hospital Professional Awards held in September this year. Sarah undertook her Pharmacy degree and M.Pharm in Royal College of Physicians Ireland (RCSI) after completing a biochemistry degree from Trinity College. She completed her Pharmacy internship in St. James’s hospital prior to joining the Pharmacy department in the Mater Misericordiae Hospital in 2012. The Mater Misericordiae University Hospital (mmuh) is a tertiary ophthalmology referral centre which treats complex ophthalmic conditions. Extemporaneous eye drops are required to treat acute ophthalmic conditions when a commercial alternative is not available. When patients being treated with extemporaneously compounded eye drops are being discharged, the MMUH ophthalmology pharmacist liaises with the patients’ community pharmacies, providing aseptic preparation guidelines, individual eye drop protocols and a manufacturing pack. Additionally, Sarah ensured that these protocols were available on the hospital intranet (maternet) for nursing and medical colleagues as required in the eventuality that extemporaneous eye drops are required to be made out of hours. Sarah, in collaboration with the

Sarah Molony, Medicines Information/Clinical Pharmacist, Mater Misericordiae University Hospital

Dispensary Service Manager, Maria Creed, firstly reviewed and updated the extemporaneous eye drop protocols and aseptic preparation guidelines to ensure they were easily understood and up to date. Additionally, Sarah ensured that these protocols were available on the hospital intranet (maternet) for nursing and medical colleagues as required in the eventuality that extemporaneous eye drops are required to be made out of hours. It is essential that there is no disruption to treatment upon the patients discharge. Sarah wished to ensure that her community pharmacy colleagues were supported as much as possible in order to ensure that patient care was not compromised upon their discharge. In addition to the provision of written support material, she developed a video in collaboration with the senior Pharmacy Technician, Catherine field and the biomedical imaging and media services department in MMUH to demonstrate the process of compounding extemporaneous eye drops. Sarah has worked with her pharmacist and Pharmacy Technician colleagues within the pharmacy department to ensure that the extemporaneous eye drop protocols were systematically updated to reflect the actual procedure of compounding eye drops in a safe manner. Sarah uploaded these protocols to the hospital intranet (the maternet) to allow out of hours access to these protocols. This ensured that regardless of when a patient was admitted that there was no delay in essential

sight saving treatment, for example with the availabilitity of the protocols, an extemporaneous antifungal eye drop could be compounded by nursing staff out of hours. Sarah is in continual communication (verbal and via email) with community Pharmacy colleagues prior to patients’ discharge to ensure the process of discharge is seamless and that importantly, there is no interruption to this vital medical treatment for the patient. Sarah went on to further enable community pharmacy colleagues by developing an extemporaneous eye drop video in conjunction with Catherine Field and the biomedical and media services department. She was chosen to present at the Hospital Pharmacist Association of Ireland Conference on the initiative and has been in touch with extemp.ie who have agreed to host the video. Additionally, Sarah is in liaison the Irish Institute of Pharmacists who are interested in hosting the video.

• Making extemporaneous eye drop protocols available electronically in MMUH via the hospital intranet (maternet) ensuring when protocols are required out of hours that there is no delay in patient treatment • Development of a video demonstrating the process of compounding Extemporaneous eye drop protocols to aid community pharmacy colleagues when compounding the eye drops and to ensure that optimal patient care is achieved for the patient while an in-patient and upon discharge • Development of an interdepartmental policy on extemporaneous eye drops which was approved by the drugs and therapeutics committee.

The key areas or service improvement introduced by Sarah include:

Sarah is an innovative Clinical Pharmacist who has the ability to identify where service development can be achieved and determines how best to achieve this. Sarah’s work as an ophthalmology specialist has greatly enhanced the provision of patient care within the MMUH for inpatients and importantly for patients upon discharge.

• Updated extemporaneous eye drop protocols within MMUH

Sarah’s work within the speciality of ophthalmology has aided the

HPN • Professional Top100 - 2016


HPN Awards: Hospital Specialist 2016 Sarah Molony, Medicines Information/Clinical Pharmacist, Professor Ciaran Meegan Head of Pharmacy Services and Deirdre Lenehan, Drug Safety Facilitator, Mater Misericordiae University Hospital

Changing the needle on a syringe

provision of a useful educational tool which impacts greatly on patient care. She works well with medical, nursing and pharmacy colleagues. She develops a good rapport with patients and with community pharmacy colleagues. She acknowledges the strength of her colleagues and has learned and developed the Ophthalmology service in conjunction with her pharmacy and pharmacy technician colleagues.

Preparing Exemporaneous eye drops

Awards

Screen shot from You Tube of Sarah's video

Hospital Professional

Professional Top100 - 2016 • HPN

2017

The Mater Misericordiae University Hospital is a tertiary ophthalmology referral centre which treats complex ophthalmic conditions. Extemporaneous eye drops are required to treat acute ophthalmic conditions when a commercial alternative is not available. When patients being treated with extemporaneously compounded eye drops are being discharged, the mmuh ophthalmology pharmacist liaises with the patients’ community pharmacies, providing aseptic preparation guidelines, individual eye drop protocols and a manufacturing pack. Additionally, the pharmacist fields calls from community pharmacists and answers questions in relation to the preparation of these drops. Anecdotally, community pharmacists can be reluctant to extemporaneously compound eye drops due to perceptions that it is a complicated process and also a fear of undertaking a procedure not routinely practiced by them.

Feedback from community pharmacy users of the multimodal communications methodologies has been extremely positive. The project represents collaboration between hospital and community for the betterment of patient care. Sarah was chosen to present at the hospital pharmacist association of Ireland Conference on the initiatives and she has gone further to ensure that this educational tool is available for community pharmacies and for hospital pharmacists besides those who’s patients attend the mmuh by having the video accessible on Youtube®. Addtionally, sarah has arranged for a link to the video to be hosted on Extemp.Ie and has been in contact with the iiop to facilitate further distribution. Chief Pharmacist Jenn Brown says, “Sarah is one of our younger Pharmacists who has just completed her Masters and who has completed a great deal of excellent work within the ophthalmology specialist field recently. This Award serves as great recognition for this work that she has done not only for her patients but for both hospital pharmacists and community pharmacist colleagues.”

Sarah Molony won the HPN Hospital Specialist of the Year 2016 Award.

Hospital Professional Awards 2017, Saturday September 16th, 2017, Clayton Hotel (Burlington) Dublin


News 59

Doctors must have confidence in Open Disclosure, says IMO The Irish Medical Organisation has said Doctors as well as patients must have confidence in the Open Disclosure process, adding it is ‘essential therefore that both the proposed legislation and the standards to be set by HIQA and the Mental Health Commission are concise and unambiguous.’

Dr John Duddy IMO

The medical body was giving a statement to the Oireachtas Health Committee on Open Disclosure Provisions to be contained in the Civil Liability Amendment Bill . “The IMO supports Open Disclosure not only as a measure to prevent litigation but more importantly because patients have the right to an apology and explanation when things go wrong,” they said. “Doctors and other healthcare professionals have a duty to be open, honest and transparent with patients, to reflect on adverse events and to take steps to ensure that such incidents are not repeated. Open Disclosure is not about apportioning blame but rather about keeping patients informed about investigations and preventing future patient safety incidents. Open Disclosure recognises that healthcare professionals are the second victims of patient safety incidents and successful policies ensure that both patients and healthcare staff alike are supported throughout the disclosure process and the patient safety investigation.

IMO doctors are increasingly concerned about the effects of successive budget cuts and reduced staffing levels on patient safety and quality of care. practitioners from admitting liability and from fitness to practise hearings when apologising to patients following an adverse event.

“The practice of medicine is increasingly complex and while the majority of healthcare professionals aim to provide the best care for their patients, incidents do occur. Rarely harm is due to wilful misconduct, most often harm is due to systems failure or unintentional human error. Patients are entitled to a full and open disclosure including an apology following an adverse event.

“Therefore the IMO welcomes the proposed Bill. Doctors as well as patients must have confidence in the Open Disclosure process and it is essential therefore that both the proposed legislation and the standards to be set by HIQA and the Mental Health Commission are concise and unambiguous. The purpose of the legislation is to ensure that Open Disclosure is not an admission of liability and therefore even the fact that an open disclosure is made cannot be construed as an admission of liability. Standards for disclosing patient safety incidents must ensure that disclosure is timely, factual and that principles of patient consent and confidentiality are protected. There must be clarity of responsibility for disclosure.

“Fear of litigation, fitness to practise procedures and damage to reputation have been identified as major barriers to apologising to patients following an adverse event. The IMO has been calling for a number of years for legislation to support Open Disclosure and to protect medical

“While legislation will provide doctors with medico-legal clarity when it comes to apologising, Open Disclosure policies can fail without an organisational culture that supports open disclosure. Open disclosure is stressful and time consuming. Often it can take some time to establish the facts,

there may be differences in opinion or a breakdown in communication. “The evaluation of the HSE’s National Open Disclosure pilot identified a number of critical success factors to Open Disclosure and recommended that the roll-out across the HSE include a supportive hospital environment and supportive organisational culture, leadership, sufficient resources within the hospital including a risk management department with expertise to support and engage clinical and non-clinical staff in Open Disclosure, good quality training, clear guidance on reporting and multi-disciplinary approaches to reporting and learning. “In addition to developing standards for open disclosure, the Department of Health, the HSE and other healthcare organisations must ensure that all the supportive structures and resources are in place to support Open Disclosure not only in hospitals but also in general practice and community settings including education and training programmes, support from colleagues and line managers, guidance material, counselling services, risk management teams. There must be some recognition that Open Disclosure will reduce time spent on clinical duties.

“Finally greater focus must be made on prevention of patient safety incidents. IMO doctors are increasingly concerned about the effects of successive budget cuts and reduced staffing levels on patient safety and quality of care. OECD figures from 2013 show that Irish public hospitals operate at 93.8% capacity, a figure well over the established safe occupancy threshold of 85%, and above the identified 92.5% tipping point that has been shown to result in significantly higher patient mortality, due to rationing of resources and elevated stress levels. The largest barrier to patient safety in the country is the low number of medical specialists per head of population and the inadequate distribution of resources based on medical or social need. Our health services are significantly over stretched and clinicians are dealing with a constant stream of emergency patients without time or resources to adequately engage in audit and patient safety and quality improvement initiatives. “It is imperative that all clinical services operate with sufficient minimum financial and manpower resources necessary to provide safe, quality, evidence-based care.”

HPN • Professional Top100 - 2016


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Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional 100,ofHospital Awards, Professional 100, Hospital Professional The HPN Professional Top 100 is a Top network the mostProfessional influential hospital professionals fromTop a number of disciplines, both News, Professional Top in a healthcare pharma industry role, who act as Top ambassadors and role models forNews, their peers, colleagues and the Hospital rising 100, Hospital and Professional Awards, Professional 100, Hospital Professional Professional Top 100, Professional Awards, stars of tomorrow. Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Hospital Awards, Professional Top Professional 100, Hospital If you’re looking for inspiration, youTop can 100, read about the Professional amazing individuals who shape the HPN TopProfessional 100 for 2016News, Professional Top on theHospital forthcoming pages. Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, 100, Professional Professional Topmonths, 100, Hospital Professional News, Professional TopClinical 100, Hospital Professional Awards, Professional Top 100, Hospital Over the past many we reached out to Pharmacists, Consultants, Specialists, representative bodies and organisations throughout the sector and encouraged them to put Professional forward thoseNews, professionals they feel are setting the

Hospital Professional 100

landscape for the future.

Those who have made our final list have displayed motivating behaviour affecting the development of hospital services within Ireland. Featured in this year’s list are people from a variety of backgrounds. Though the roles our finalists play in are diverse, everyone of them has one thing in common: an unfailing commitment to the development of the hospital healthcare sector.

Improving clinical, scientific and commercial results


Professional 100 John Fitzpatrick Research Recipient Dr Emma Allott has this year been awarded the Professor John Fitzpatrick Research Fellowship – a threeyear grant award worth over ¤200,000, which was established by the Irish Cancer Society, the Dana-Farber Cancer Institute and Harvard T.H. Chan School of Public Health to fund an Irish scientist or clinician to undertake high quality research into prostate cancer. Over the next three years, Dr Allott will investigate if high cholesterol levels impact survival rates in men with advanced prostate cancer. More specifically she will investigate if reducing cholesterol levels has the potential to improve survival rates when combined with hormonal treatment.

Dr Emma Allott, John Fitzpatrick Research Fellowship Recipient, 2016

Excellence in Tissue Regenerative Medicine During 2016 Professor Frank Barry has contributed to the fields of tissue engineering and regenerative medicine by developing innovative and successful cellular therapies for tissue repair, joint injury and arthritic disease. He directs a large group of researchers who focus on the development of new repair strategies for musculoskeletal conditions, especially osteoarthritis. Previously he was Director of Arthritis Research at Osiris Therapeutics in Baltimore, MD and a Research Fellow at Shriners Hospital for Children, Tampa, FL. In a career that has spanned both industry and academic research, he has been a driver in the development of cellular therapy as a biological repair strategy. It is his belief that the application of new technologies in regenerative medicine, including cellular therapy, gene therapy, growth factor augmentation, implantable scaffolds and nanomaterials, will have a profound impact in medicine in years to come. Professor Frank Barry, Professor of Cellular Therapy at the Regenerative Medicine Institute, NUI Galway

Awarded the Burkitt Medal for Cancer Research Dr Paul Brennan, Head of the Genetics Section of the International Agency for Research on Cancer (IARC), Lyon, has been awarded the 2016 Burkitt Medal for his contribution to cancer research. The award recognises people with the integrity, compassion and dedication matching that of Denis Burkitt, a Trinity graduate who is known for his discovery of Burkitt lymphoma. Dr Brennan received the medal during the 10th International Cancer Conference, which was recently held in Trinity College Dublin under the theme New Frontiers in Personalised Cancer Care. Dr Paul Brennan received the Burkitt Medal after delivering the Burkitt Lecture: “Cancer Prevention: from Denis Burkitt to the Human Genome Project,” at the Cancer Conference. Dr Paul Brennan, Head Genetics, International Agency for Research on Cancer

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Professional 100 Managing Pharmacy Infectious Diseases The Infectious Diseases services in the Mater Misericordiae University Hospital continue to evolve and expand under the lead of Catherine. In 2016 Catherine has been increasing patient numbers receiving treatment for HIV, the expansion of treatment for Hepatitis C infection and the emergence of clinical trials and service developments in this field, offering many opportunities for specialist pharmacy services. Catherine is managing these exciting service developments within the MMUH.

Catherine Boyle, Pharmacy Lead Infectious Diseases

Implementing Medicines Evaluation In the MMUH, balancing access to new medicines with on-going cost containment is an organisational priority and reflects applicable national strategy. Jennifer has been instrumental in the implementation and evolution of medicines evaluation and approval strategies in the MMUH to provide greater quality, access and safety of medicines use. The work undertaken reflects emerging medicines management issues. Within Jennifer’s remit, in collaboration with multiple stakeholders, policies have been established in the MMUH to optimise the medicines selection and approval processes. Jennifer Brown, Pharmacy Head of Operations, Mater Misericordiae University Hospital

A Leading Force in Pharmacy Re-location Marie-Claire Jago-Byrne is the Chief Pharmacist at Naas General Hospital and has been considerably instrumental in a vast number of areas, including, but not limited to, in the design, layout, structure, size and general aesthetic of the new Pharmacy department and in the smooth operational transition from the old Pharmacy department to the new. She also set up and organised the new service delivery model. Under Marie-Claire’s leadership, the Pharmacy team at Naas General Hospital won the title of Hospital Pharmacy Team of the Year in 2014.

Marie-Claire Jago-Byrne, Chief Phamacist, Naas General Hospital

Championing Wellness at Work In 2016 Pat Campion and Lundbeck have launched the Aware ‘Wellness@Work Programe’. This has delivered 141 talks in 2015 to a wide variety of organisations and so far year to date they have delivered 115 talks in 2016. It has been delivered to just under 4,000 participants since the launch in 2015. The response has been excellent with a great deal of positive feedback. Pat’s career spans 20 years in the pharmaceutical industry, with Lundbeck Ireland for the last 10 years and in the position of Country Manager for the last three years. Lundbeck is a company solely focused and specialised in the area of mental health. Pat Campion, County Manager, Lundbeck

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Professional 100 Top Pharma Award for Training In 2016 NIBRT co-hosted Biopharma Ambition, a multi-platform event to inspire and showcase innovation. The event highlighted the ambition of the industry for the health and well-being of populations. It showcased the latest research and how Ireland will support innovation in discovery, development, manufacturing and healthcare solutions. NIBRT was also recognised this year with two awards at the Irish Pharma Awards: • Pharma Education & Training Award • Partnership Alliance of the Year Mr Carolan was appointed CEO of NIBRT in April 2015. He has successfully lead the startup of two significant Pharma and BioPharma facilities in Ireland and has a proven track record in operations leadership and in attracting and developing the talent required to deliver long term success. Dominic Carolan, CEO, National Institute for Bioprocessing Research & Training

Pioneering Integrated Care for the Elderly Over the last year, Dr Carroll has focused on establishing the operating model for the ICPs after recognising the importance of ensuring the plans have the appropriate support and sign-off, appropriate monitoring and actually achieve their targets. The Prevention and Management of Chronic Disease ICP was tested in pioneer areas to test the proof of concept. In 2016, the ICP for Older Persons has selected and worked with at least one integrated care pioneer area to test and deploy a model of integrated care for older persons that aligns with existing improvement initiatives. Further pioneer areas will be developed and will ultimately form an improvement network, linked with international integrated care improvement best practice. Dr Áine Carroll, National Director, Clinical Programmes

Placing Ireland on the Global Health Agenda Ms Emer Cooke, a TCD School of Pharmacy and Pharmaceutical Sciences graduate and current member of the School’s Strategic Advisory Board, took up an appointment in 2016 as Head of Regulation of Medicines and other Health Technologies with the World Health Organisation (WHO) in Geneva. In this role, Ms Cooke will be responsible for leading WHO's global work on regulation of health technologies (medicines, vaccines, diagnostics and devices), co-ordinating the regulatory teams (Norms and Standards, Prequalification, Regulatory Systems Strengthening, and Safety), and working with member states and international partners to assure the quality, safety and efficacy of appropriate health technologies.

Ms Emer Cooke, Head of Regulation of Medicines, World Health Organisation

Using Lean to Streamline Services Maria is the Dispensary Services Manager in the MMUH with responsibility for co-ordinating and supervising the distribution and storage of medicines for the hospital. In her role as Dispensary manager, Maria’s was project lead in a Lean Green Belt project which used lean methodology to revise the controlled drug supply process hospital wide and resulted in a reduction in nurse visits to the Pharmacy Department monthly. Maria is currently undertaking her LEAN Black Belt qualification. Maria Creed, Dispensary Services Manager, Mater Misericordiae University Hospital

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Professional 100 A First of Clinical Nursing for Ireland Ms Helen Connaughton, a nurse working at Tallaght Hospital, has become the first Clinical Nurse Specialist in Ireland in the area of Inherited Cardiac Conditions. As the first Irish Clinical Nurse Specialist in this field, Ms Connaughton is now a national leader in this area and demonstrates the investment and advancements that have taken place in cardiac services at Tallaght Hospital. Ms Connaughton was a Clinical Nurse Manager in the Cardiac Risk in the Young (CRY) unit for eight years. The CRY unit aims to provide comprehensive specialist evaluation of those diagnosed with or at risk from inherited cardiac conditions, including families who have lost someone to sudden cardiac death. It was developed as a collaboration between Tallaght Hospital, St James’s Hospital, St Vincent’s University Hospital and Trinity College Dublin and is located at Tallaght Hospital.

Helen Connaughton, Clinical Nurse Specialist, Tallaght Hospital

Leading the Digital Revolution Richard Corbridge took up the dual role within Ireland of CIO of the Health Service Executive and the role of Chief Officer of the newly formed eHealth Ireland organisation, a new structure responsible for the delivery of an eHealth Eco-System for Ireland that will facilitate the health informatics innovation delivery country wide, in 2014. He is an accomplished innovator who has streamlined systems at the NHS and who was ranked among the top 100 CIOs in the UK.

Richard Corbridge, Chief Information Officer, HSE

Leading Acute Medicine Nationally Professor Garry Courtney is the Clinical Lead of the National Acute Medicine Programme. He graduated in Medicine from Trinity College, Dublin University. He trained in General Medicine and Gastroenterology in Dublin and London and was appointed a Consultant Physician and Gastroenterologist in St. Luke’s Hospital, Kilkenny in 1996. He is a member of the Executive of the Ireland East Hospital Group. Other appointments include, Associate Professor of Medicine at the Royal College of Surgeons in Ireland and College Tutor, the Royal College of Physicians of Ireland. He is the Clinical Director in St Luke’s Hospital, Kilkenny, where he continues to be a pioneer in developing alternative routes for pathways for patients through the hospitals system. Professor Garry Courtney, Clinical Lead, National Acute Medicine Programme

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Professional 100 Changing Programmes Through Strategy Professor Colette Cowan has this year been leading the University of Limerick Hospitals Group through a change programme in line with the groups' strategic plan. Earlier this year the Group published a ambition four-year plan identifying some 60 priority actions to improve the health and wellbeing of the c 380,000 people it serves and the 3,300 staff it employs. She has also been driving the development of the hospital group to achieve Trust Status over the coming years. Professor Cowan is former Director of Nursing at Nenagh Hospital and has over 26-years experience working in the Irish health service, 15 of which are in management. Most recently she was Acting CEO & Chief Director of Nursing and Midwifery for the Saolta University Healthcare Group (previously known as the West North West Hospitals Group). Professor Colette Cowan, CEO, University of Limerick Hospitals Group

Formidable Influence for Women in Business During her tenure as President of IPHA, Dr Leisha Daly successfully led the team agreement with the Government on a new 4 four year framework for the pricing and supply of medicines in Ireland. She has also been recognised as one of Ireland’s 25 most influential and powerful women by the Women’s Executive Network (WXN) for her contribution to Janssen Ireland, the pharmaceutical industry and the community. Dr Daly graduated with a PhD in Clinical Medicine from Trinity College Dublin in 1989 and following some years in clinical research she joined the pharmaceutical industry as technical advisor for Hoechst Ireland. She joined Janssen as Head of Technical Affairs in 1998, and since then has served in a variety of senior positions in medical, sales and marketing. During her tenure, Janssen has become one of the fastest growing pharmaceutical companies and the 8th largest pharmaceutical company overall in Ireland.

Dr Leisha Daly, Janssen, Former President, IPHA

Founding Member of NIBRT Professor Gavin Davey is based at the Trinity Biomedical Sciences Institute and runs a research group with particular interests in glycobiology, neurodegeneration and next generation biopharmaceuticals. Gavin has 26 years’ experience in the area of enzymology and metabolic flux, particularly in relation to mitochondrial bioenergetics and cellular metabolism. In recent years his group has focussed on (1) investigation of mitochondrial energetics and fusion/fission dynamics specific to cancer cells and neurons (2) identification of metabolic control points as new targets for anti-cancer therapeutics (3) understanding control of N-linked and O-linked glycosylation pathways in cancer and immune cells (4) glycoengineering IgG biotherapeutics for enhanced ADCC, CDC and enhanced immunomodulatory. Professor Davey is a founding member of NIBRT (National Institute for Bioprocessing Research & Training) and Glycoscience Ireland, a member of the NIBRT scientific advisory board and currently leads a range of industry-academia research projects mainly focussing on novel technologies for glycoengineering biotherapeutics.

Professor Gavin Davey, Head of School of Biochemistry and Immunology, Trinity College Dublin

Leading Ireland East Hospital Group Mrs. Mary Day has been the Chief Executive Officer of Ireland East Hospitals Group at Health Service Executive since October 1, 2014. Mrs. Day serves as the Chair of Executive Management Committee and Chief Executive Officer of Mater Misericordiae University Hospital Ltd. and also served as its Director of Nursing. She serves as a Director of Mater Misericordiae University Hospital Ltd. Mrs. Day's professional career includes a two-year term in the Department of Health & Children as Nurse Advisor in Professional/Practice Development, being responsible for supporting the Nursing Policy Division and advising the Department on all aspects of policy affecting nursing and midwifery education and healthcare services. Mrs. Day continues to be instrumental in policy and practice development in Ireland. Professor Mary Day, CEO, Ireland East Hospital Group

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Professional 100 Merging Pharmacy with Education Tim Delaney is Head of Pharmacy at Tallaght Hospital. In September of this year he was a key member of the Tallaght team formalised the relationship between Tallaght Hospital and Trinity College Dublin with the signing of a formal Memorandum of Understanding to further enhance the education and professional development links between both bodies. Tim has had a career-long interest in medication safety. Under his leadership Tallaght Hospital established the first hospital medication safety programme in Ireland in 2000. Many other hospitals have borrowed from their model which won the 2006 Irish Society for Quality and Safety in Healthcare National Quality & Safety Award. He has published numerous research articles and opinion pieces, on topics relating to medication safety, medication reconciliation, quality management, safety culture and process improvement in medication use.

Tim Delaney, Head of Pharmacy, Tallaght Hospital

Taking IPHA forward into 2017 In 2016 Mary Dickens was appointed President of the Irish Pharmaceutical Healthcare Authority. In this position Ms Dickens represents the research-based pharmaceutical industry in Ireland and continues to demonstrate the key role the industry plays as a partner in healthcare provision. In July of this year IPHA agreed a new four year Framework Agreement with the Government for an economic and secure supply of medicines for patients. The Agreement will see total savings of ¤785 million from IPHA member companies, an average of nearly 200m a year. She is the Country Chair and General Manager of General Medicine of Sanofi Ireland Ltd. Mary Dickens, President, The Irish Pharmaceutical Healthcare Association

She has been a member of the IPHA Strategy Board since September 2011 and was appointed to the Board of Directors in November 2012. She joined the Sanofi Group in 1984 as a Medical Representative in the UK and held various positions including Regional Business Manager before returning to Ireland in 1999 to join Abbott Laboratories as Divisional Manager.

From Bedside to International Stage Professor Seamas Donnelly is an international leader in Translational Medicine and his research epitomizes classical bench to bedside on an international stage. The work of his research group creates clinical, genetic, biological and sensor datasets which allows more focused patient stratification with regards to patient prognosis and ultimately getting the right treatment to the right patient – the focus of Precision Medicine. He was one of the first clinicians to be awarded a Science Foundation Ireland (SFI) Principal Investigator Programme grant award which was recently renewed for a further 5 years. This work has focused on the development of novel small molecular-weight anti-inflammatory agents targeting chronic inflammatory diseases particularly pertaining to the lung. He is the Trinity lead PI on the recently awarded on the Enterprise Ireland funded National Health Innovation Hub.

Professor Seamas Donnelly, Trinity Biomedical Sciences Institute

Innovation in Compassionate Use Programmes In early 2016, Garreth was promoted to Deputy Aseptic Compounding Service Manager within the Mater Misericordiae University Hospital. Together with his manager, this involves managing a very busy Aseptic Compounding Unit (ACU) in the provision of chemotherapy and clinical trials to the Oncology/Haematology Day ward and inpatient ward. This year has also brought about a huge increase in numbers of Compassionate Use Programs (CUP’S) that are available to patients at MMUH. Garreth has played an integral part working closely with the Pharmacy Departments Head of Operations in the initiation of such programs overseeing the funding structures of same and the workload implications on the ACU service. Furthermore, protocol development, dispensing and compounding as appropriate applies to all CUP’s. Garreth Dooley, Deputy Aseptic Services Manager/ Oncology/ Haematology Clinical Trials

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Professional 100 Excellence in Patient Safety Award Winner There are three projects used as examples of Nuala Doyle’s input into the Pharmacy Department including the review for the first time since the 1990’s of the existing drug Kardex to the now implemented MPAR; the coordination and implantation of the care of the elderly initiative and liaising with the HSE Clinical Lead Medication Safety Programme and allowing Beaumont Hospital Pharmacy Department to be the pilot site for the national guidelines for VTE prophylaxis (ongoing). Since taking up post as the first Medication Safety Pharmacist in Beaumont Hospital in 2010 Nuala has raised the profile of medication safety in the hospital and made a significant contribution to changing the safety culture within the hospital.

Nuala Doyle, Chief Pharmacist, Beaumont Hospital

Leading the Irish Medical Organisation Dr John Duddy is the current President of the Irish Medical Organisation. He is a Specialist Registrar in Neurosurgery and Lead NCHD at Beaumont Hospital Dr Duddy graduated from Trinity College Dublin in 2002 with a BA in Computational Chemistry. He then studied Medicine at UCC, graduating in 2008. He completed internship and basic surgical training at the Mercy University Hospital, Cork and Cork University Hospital. He then worked as a Neurosurgery Registrar at Beaumont Hospital and Children's University Hospital Temple Street, and obtained a Masters in Surgery at RCSI. He is now a Specialist Registrar in Neurosurgery and Lead NCHD at Beaumont Hospital.

Dr John Duddy, President, Irish Medical Organisation

Major Milestones for the Mater Mr Gordon Dunne is the CEO of the Mater Hospital. The Mater Lean Academy celebrated a milestone recently when it trained its 1000th person in the Fundamentals of Lean. The mission of the Mater Lean Academy is to improve healthcare quality and safety for patients and their families and to generate efficiencies for all healthcare professionals and support staff. Mr Dunne joined the Ireland East Hospital Group in February 2015 as Chief Operating Officer following four years as Chief Executive of Cappagh National Orthopaedic Hospital, a role he retains. Gordon Dunne, CEO, Mater Misericordiae University Hospital

Under Mr Dunne’s leadership, Cappagh received a major international quality improvement award. He was also responsible for the successful completion of significant infrastructural projects, including new theatre suites, recovery room, a 10-bed isolation unit and commercial Central Decontamination.

Chairing Health Research

Professor Joe Eustace, Director, HRB Clinical Research Facility

Professor Joe Eustace is the Director of the HRB Clinical Research Facility at UCC. He graduated MB, BAO BCh (UCD) 1990 and undertook postgraduate training in General Internal Medicine and Nephrology in Dublin (1990-1996), Johns Hopkins University Hospital, Baltimore (19961999), and a NIH funded Fellowship in Clinical Epidemiology at the Johns Hopkins Bloomberg School of Public Health, (1997-1999), as part of which he undertook a MHS (Clin Epi) degree. Professor Eustace is the chair of the senior management team of the recently launched HRB Clinical Research Coordination Ireland (HRB -CRCI), which will give more Irish people access to multi-centre clinical trials. HRB CRCI will deliver widespread benefit; helping patients understand more about clinical research and participating in trials, assisting health professionals to get involved in clinical research, helping the life sciences industry deliver high quality clinical research in Ireland and guiding academics to develop research proposals which involves patients.

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Professional 100 Overseeing Tallaght's First National Report Dr Daragh Fahey is a graduate of University College Dublin and is currently the Director of Quality Safety & Risk Management at Tallaght Hospital. As part of his work he led the production of the Hospital’s first ever stand-alone Quality Report in 2015, which outlined some of the key services, initiatives and achievements which staff at Tallaght Hospital have undertaken under the three pillars of Quality, Safety and Risk Management. As part of this work he also catalogued over 50 Quality Improvement Initiatives that were completed at the Hospital in 2015 including the development of Rapid Access Clinics and a physiotherapy treatment room at ward level.

Dr Daragh Fahey, Consultant Medical, Opthalmology

Outstanding Performance in Research Professor Des Fitzgerald has been announced as the next President, University of Limerick (UL) succeeding Professor Don Barry whose term of office ends in April 2017. Professor Fitzgerald is currently UCD Vice President for Health Affairs and inaugural Chief Academic Officer, Ireland East Hospital Group. He previously served as Vice President Research at UCD (2004 – 2014) and has held senior leadership roles including Director of Research and Professor of Clinical Pharmacology at the Royal College of Surgeons in Ireland. He played a pivotal role the transformation of UCD’s research performance in competitive, internationally-judged research programmes funded by the EU, PRTLI and Science Foundation Ireland. Achievements include the establishment of the UCD Science Centre, the National Institute of Bioprocessing Research and Training, the National Digital Research Centre, and the UCD Charles Institute for Dermatology Research and Training, while also securing national leadership for UCD in EU FP7 funding. Professor Des Fitzgerald, President, University of Limerick

Innovation & Service Development Award Winner This submission detailed their project entitled – ‘Optimisation of Lithium Therapy - Exploring innovative ways to provide Medicines Education.’ Incorporating the NHS England guidance on medicines optimisation, the team explored a cost effective intervention to optimise medicines use and ensure it is deliverable and affordable on the scale required for their target demographic , a large number of service users in rural/urban areas throughout the country. Results suggest that providing lithium education through a multimedia format with a combination of visual and verbal methods increased knowledge and understanding of lithium treatment for over 86% of participants and 80% agree that they find it a better information resource than leaflets.

Amanda Fitzpatrick, Head of Pharmacy, St Patrick’s University Hospital

Addressing Antibiotic Resistance Dr Fidelma Fitzpatrick has during 2016, spoken out about the fight against antibiotic resistance. A multi-pronged approach is required to tackle antibiotic resistance, including the development of a rapid, point-of-care test for bacterial infections, she had said.

Dr Fidelma Fitzpatrick, Beaumont Hospital

Dr Fitzpatrick is a Senior Lecturer, Royal College of Surgeons in Ireland and Consultant Microbiologist, Beaumont Hospital, Dublin, Ireland. As the first National clinical lead for the prevention of healthcare-associated infection (HCAI) and antimicrobial resistance (AMR), she established the national clinical programme and oversaw the transition of governance of the functions of the SARI (Strategy for the Control of Antimicrobial Resistance in Ireland) national committee to the Royal College of Physicians of Ireland (RCPI) and the HSE.

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Professional 100 Idis Hospital Pharmacist of the Year 2016 Michael Fitzpatrick is currently Head of Pharmacy Services at OLCHC and Pharmacy Lead for the new National Children’s Hospital. He joined the pharmacy team in Crumlin ten years ago and in that time he has accomplished a vast amount both within and outside of the hospital setting. He has been the leading figure on a number of major changes in the department and within the paediatric hospital circuit. Michael is a diverse character; having previously worked as a pharmacy technician; followed by some time in the private hospital sector and then eventually evolving to his role as the Head of pharmacy services in OLCHC. Managing people is a massive component of the role of chief pharmacist. He has exceptional communication and people skills and this is evident from the respect and hard work that is seen from his staff. Earlier this year he won the title of Hospital Pharmacist of the Year 2016.

Michael Fitzpatrick, Chief Pharmacist, Our Lady’s Children’s Hospital

Chair in Pharmachemicals Seamus is current Chair of BioPharmachem Ireland and during 2016 together with IPHA and NIBRT they hosted a multi-platform event to inspire and showcase innovation. BioPharmaAmbition 2016 showcased the latest research and how Ireland will support innovation in discovery, development, manufacturing and healthcare solutions. Seamus is the Pfizer Ringaskiddy & Little Island API, Site Leader. Seamus has worked his entire professional career in manufacturing and loves the dynamic nature of manufacturing. After qualifying as a Chartered accountant Seamus worked in various Finance roles in the food industry. Seamus joined Warner Lambert in Loughbeg API in 1997 and was subsequently Finance Leader for Loughbeg and Little Island (March 1998); Production Leader, Little Island (2002); Production Leader, Loughbeg API (2003); Plant Network Strategy team leader for Ireland ( 2006); Finance Team leader for Ireland Singapore; Site Leader, Little Island (June 2008) and became the Site leader for both the Ringaskiddy & Little Island Site in January 2011.

Seamus Fives, Chairman, BioPharmaChem Ireland

From Discovery to Development Dr Gerard Fox is Senior Director, Global Discovery at AbbVie. As a member of AbbVie’s Global Pipeline and Discovery Leadership Teams he shares responsibility for the advancement of new molecules from discovery to clinical development. Gerry’s focus includes cystic fibrosis, liver disease, future therapeutics and technologies, translational imaging and safety pharmacology. He is Head of AbbVie’s collaboration with Calico, a new initiative aimed at increasing the understanding of the biology that controls lifespan and using that knowledge to devise interventions that enable people to lead longer and healthier lives. He currently serves as Affiliate Faculty member at Roosevelt University in Chicago, Visiting Professor at Capital Medical University in Beijing, and Visiting Lecturer at University of Illinois, Urbana-Champaign. Gerry is also author, coauthor or inventor of more than 120 scientific papers, book chapters and patents. Dr Gerard Fox, Senior Director & Head, Calico Collaboration, AbbVie

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Professional 100 Building a Culture of Knowledge Dr Aoife Gallagher is Head of Innovation with the RCSI. The goal of the team RCSI’s Innovation team is to work with RCSI Principal Investigators (PIs) to ensure that RCSI research is given the best opportunity to make economic and societal impact through the provision of customer-orientated industry engagement and research commercialisation services to researchers and industry partners. In 2015, the team launched a new strategic initiative "Building a Culture of Knowledge Transfer at RCSI" to maximize researcher engagement in knowledge transfer activities to achieve this goal. In June, RCSI's Innovation team has won the Knowledge Transfer Initiative of the Year Impact Award at the national Knowledge Transfer Ireland Impact Awards 2016.

Dr Aoife Gallagher, Head of Innovation, RCSI

Clinical Research in Breast Cancer

Professor William Gallagher, Director, UCD Conway Institute

Professor William Gallagher is the Director of the UCD Conway Institute and a Professor of Cancer Biology in the UCD School of Biomolecular & Biomedical Science. He is currently also the Director of the ¤7.5Mi BREASTPREDICT Centre (www.breastpredict.com), which is the first Irish Cancer Society Collaborative Cancer Research Centre, involving 6 universities and Cancer Trials Ireland. Professor Gallagher is lead investigator on a Science Foundation Ireland (SFI)-funded Investigator Programme (IvP) project, OPTiPREDICT, which is centred on developing novel clinical decision support systems in breast and prostate cancer. Professor Gallagher currently co-ordinates the FP7 Marie Curie Industry-Academia Partnerships and Pathways (IAPP) programme, SYSMEL (www.sysmel.com), which is focused on applying systems medicine approaches to development of new diagnostic solutions in melanoma.

Advancing the Role of the Pharmacist Ms Patricia Ging is an enthusiastic and dedicated pharmacist with a passion for clinical excellence. She is an acknowledged pharmacy expert in both thoracic transplant and pulmonary hypertension and is an invited speaker on these topics at national and international conferences. She is a leader, advancing the role of the pharmacist by her clinical practice, research, publications, collaborative work and teaching. The Mater Misericordiae University Hospital Pharmacy Department is a busy, dynamic department. It is at the cutting edge of pharmacy practice, with numerous highly regarded clinical staff. More recent innovations in the department include a unique student programme which is built on our excellent reputation for teaching; we are also creating a niche with our revolutionary use of IT to streamline workflow.

Patricia Ging, Pulmonary Hypertension and Heart Lung Transplantation Pharmacist

Securing Diabetes Group Grant Professor Catherine Godson is Professor of Molecular Medicine at UCD. She is Director of the Diabetes Complications Research Centre, and will lead UCD’s involvement in a major new international five-year project. It is part of a new £3.7 million US-Ireland research partnership aiming to explain why some people with diabetes are at higher risk than others of developing kidney failure.

Professor Catherine Godson, Professor of Molecular Medicine, UCD

The grants have been awarded under the US-Ireland Research and Development Partnership Programme. This initiative brings together world-leading experts in diabetes and genetics research at Queen’s University Belfast, University College Dublin, University of Helsinki in Finland and the Broad Institute, Boston, USA. The findings will provide vital information that could enable personalised preventative care for people with a genetic profile that puts them at risk of developing kidney complications.

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Professional 100 Co-ordinating Pharmacy Education Dr Brendan Griffin has this year co-ordinated the launch of PEARRL (Pharmaceutical Education And Research with Regulatory Links) - a European Training Network (ETN) for innovative drug formulation strategies and biopharmaceutics tools with regulatory application. Dr Griffin’s research interests focus on the development of optimised oral drug delivery systems. This includes lipid based formulations for enhancing bioavailability of poorly soluble drug compounds; design of nanoparticulate based drug delivery systems; targeted drug delivery to the colon and to the intestinal lymphatics. He continues to interact closely with the pharmaceutical industry and has a number of research collaborations with international partners. Dr Brendan Griffin, Senior Lecturer and Course Director, School of Pharmacy, University College Cork

Excellence in Clinical Care in Neuromuscular Conditions Professor Orla Hardiman is Professor of Neurology and Academic Director of Trinity Biomedical Sciences Institute, Trinity College Dublin, and Director of the National ALS where she provides clinical care for over 80% of Irish patients with ALS, and patients with other rare neuromuscular conditions. Her research team of over 30 individuals is based at the University and at the Research Centre at Beaumont Hospital. Her interests include deep phenotyping, biomarker discovery and population genetics of ALS. She is Co- Chair of the European Network for Cure of ALS (ENCALS) and is Editor in Chief of the journal Amyotrophic Lateral Sclerosis and the Frontotemporal Degenerations. Professor Orla Hardiman, Professor of Neurology and Academic Director, Trinity Biomedical Sciences Institute

Current work focuses on the clinical and genetic overlap between ALS, frontotemporal dementia and related conditions, and on the development of novel biomarkers that underpin disease heterogeneity.

Author of Diabetes Guidelines Dr Velma Harkins is Chair of Quality and Standards with the ICGP. Dr Hawkins runs a GP practice in Banagher Co. Offaly, and has a particular interest in structured diabetes care. She was previously a Chair of the ICGP Diabetes Task Group and was the chief author of the Type 2 diabetes guidelines released by the College in February 2016. These guidelines - 'A Practical Guide to Integrated Type 2 Diabetes Care' - outline a new model of care for type 2 diabetes. Care of patients with uncomplicated type 2 diabetes will now be delivered locally for patients by GPs and practice nurses with support from clinical nurse specialists in diabetes. The guidelines have been developed to reflect the importance of GPs in managing primary care. The guidelines are an important document given the recent development of the Diabetes Cycle of Care for People with Type 2 Diabetes by the Government.

Dr Velma Harkins, Chair, Quality and Standards, ICGP

Gaining Ireland's Largest Ever Health Budget

Simon Harris, Minister for Health

Minister Harris has worked throughout 2016 to enhance health and Pharmacy services. This year secured the largest ever health budget with a total of ¤14.6 billion. After another intensive period of negotiation, he also saw through a finalised Medicines Supply Agreement which will provide substantial additional savings on the future drugs bill over the coming years. The new Agreement, which runs to the middle of 2020, is projected to result in savings – that is, expenditure foregone – of some ¤600 million from IPHA companies, with a further ¤150 million in savings anticipated from nonIPHA companies over the lifetime of the deal.The new Agreement contains a number of features which represent clear additional value over the terms of the previous 2012 agreement. It also addresses a number of issues raised by the Report on the Cost of Prescription Drugs in Ireland, issued by the Joint Committee on Health and Children in 2015.

Create Commercial Value Rethink commercialization with an unexpected mix of expertise and operational capabilities.


Taking life further in CLL IMBRUVICA® as a single agent is now reimbursed for the following indications: • The treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy or first line in the presence of 17p deletion/TP53 mutation and are unsuitable for chemo-immunotherapy • The treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) • The treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy

Destination survival

IMBRUVICA® 140 mg Hard Capsules PRESCRIBING INFORMATION ACTIVE INGREDIENT: Ibrutinib Please refer to Summary of Product Characteristics (SmPC) before prescribing. INDICATIONS: As a single agent for treatment of adult patients with: relapsed or refractory mantle cell lymphoma (MCL); chronic lymphocytic leukaemia (CLL) who are previously untreated or have received ≥ one prior therapy; Waldenström’s macroglobulinaemia (WM) who have received ≥ one prior therapy, or first line in patients unsuitable for chemo immunotherapy. In combination with bendamustine and rituximab (BR) for adult patients with CLL who have received ≥ one prior therapy. DOSAGE & ADMINISTRATION: Adults: Orally, once daily, swallowed whole with water. MCL - 4 capsules. CLL 3 capsules as single agent or in combination (refer to SmPC). WM - 3 capsules. Concomitant moderate/strong CYP3A4 inhibitors – reduce to 1 capsule (or, with strong inhibitors, withhold IMBRUVICA for up to 7 days). Withhold IMBRUVICA therapy for any new onset/worsening grade ≥ 3 non-haematological toxicity, grade ≥ 3 neutropenia with infection/fever, or grade 4 haematological toxicities. Re-initiate when toxicities resolved to grade 1 or baseline. If toxicities recur, reduce dose by 1-2 capsules. Discontinue IMBRUVICA if toxicities persist/recur following two dose reductions. Children: Safety/efficacy not established ≤ 18 years old. Elderly: No dose adjustment required. Renal impairment: Mild/moderate - no dose adjustment. Severe – no data; consider benefit/risk and monitor closely. No data with dialysis. Hepatic impairment: Mild (Child-Pugh class A) – 2 capsules daily; moderate (ChildPugh class B) – 1 capsule daily; severe (Child-Pugh class C) – not recommended. Monitor for toxicities. Severe cardiac disease: No clinical data. CONTRAINDICATIONS: Hypersensitivity to active substance/ excipients. St. John’s Wort preparations. SPECIAL WARNINGS & PRECAUTIONS: Bleeding-related events: Minor and major haemorrhagic events reported; caution with anticoagulant therapy – do not use concomitantly with warfarin or other vitamin K antagonists, avoid fish oil and vitamin E preparations. Withhold IMBRUVICA ≥ 3 to 7 days pre-/post-surgery. Leukostasis: Cases reported; consider temporary withhold of IMBRUVICA; monitor closely, give supportive care. Infections: Infections seen, some resulting in hospitalisation and death; monitor for fever, neutropenia and infections and give anti-infective therapy. Cytopenias: Treatment-emergent grade 3/4 cytopenias reported; monitor complete blood counts monthly. Interstitial Lung Disease (ILD): cases reported; monitor patients for pulmonary symptoms of ILD; interrupt IMBRUVICA and manage ILD if symptoms develop, if symptoms persist, consider risk/benefit of

IMBRUVICA treatment and follow dose modification guidelines. Atrial fibrillation/flutter: reported particularly in patients with cardiac risk factors/acute infections/previous history of atrial fibrillation; periodic clinical monitoring; consider ECG if arrhythmic symptoms or new onset dyspnoea develop; consider alternative to IMBRUVICA when pre-existing atrial fibrillation requiring anticoagulant therapy or high risk of thromboembolic disease; where no suitable alternatives to IMBRUVICA, consider tightly controlled treatment with anticoagulants. Tumour lysis syndrome: cases reported. Monitor at risk patients closely, take precautions. Non-melanoma skin cancer: cases reported; monitor patients. Effects on the QT interval: mild decrease in QTcF interval seen; use clinical judgment before prescribing for patients at risk from further shortening QTc duration. Drug-drug interactions: Strong/moderate CYP3A4 inhibitors may increase ibrutinib exposure; CYP3A4 inducers may decrease ibrutinib exposure. Avoid where possible, if not monitor closely for toxicities/lack of efficacy. SIDE EFFECTS: Very common: Pneumonia, upper respiratory tract infection, sinusitis, skin infection, neutropenia, thrombocytopenia, headache, haemorrhage, bruising, diarrhoea, vomiting, stomatitis, nausea, constipation, rash, arthralgia, musculoskeletal pain, pyrexia, oedema peripheral, muscle spasms. Common: Sepsis, urinary tract infection, nonmelanoma skin cancer, basal cell carcinoma, squamous cell carcinoma, febrile neutropenia, leukocytosis, interstitial lung disease, lymphocytosis, tumour lysis syndrome, hyperuricaemia, dizziness, vision blurred, atrial fibrillation, subdural haematoma, epistaxis, petechiae, hypertension, urticaria, erythema. Other side effects: Leukostasis syndrome, hepatic failure, angioedema. Refer to SmPC for other side effects. PREGNANCY: Women of child-bearing potential must use highly effective contraceptive measures during and for 3 months after stopping treatment; if using hormonal contraceptives, add barrier method. Not to be used during pregnancy. LACTATION: Discontinue breast-feeding during treatment. INTERACTIONS: CYP3A4 inhibitors: Strong: Avoid where possible or reduce dose (or withhold IMBRUVICA for ≤ 7 days) and monitor closely; e.g. ketoconazole, indinavir, nelfinavir, ritonavir, saquinavir, clarithromycin, telithromycin, itraconazole, nefazodone, cobicistat. Moderate: Avoid where possible or reduce dose and monitor closely; e.g. diltiazem, voriconazole, erythromycin, amprenavir, aprepitant, atazanavir, ciprofloxacin, crizotinib, darunavir/ritonavir, diltiazem, fluconazole, fosamprenavir, imatinib, verapamil, amiodarone, dronedarone. Avoid grapefruit and Seville oranges. Mild: No dose adjustment required; monitor closely. CYP3A inducers: Strong/moderate: Avoid or monitor closely for lack of efficacy; e.g. carbamazepine, rifampicin, phenytoin. Mild: may be used;

monitor for lack of efficacy. Medicines that increase stomach pH (e.g. proton pump inhibitors) may decrease ibrutinib exposure. Potential interactions: Oral narrow therapeutic range P gp or breast cancer resistance protein (BCRP) substrates (e.g. digoxin, methotrexate) should be taken ≥ 6 h before/after IMBRUVICA. Ibrutinib may inhibit BCRP in the liver and so increase exposure of drugs undergoing BCRP-mediated hepatic efflux (e.g. rosuvastatin). Ibrutinib may inhibit intestinal CYP3A4 and thus increase exposure of some CYP3A4 substrates sensitive to gut CYP3A metabolism; caution with narrow therapeutic range oral CYP3A4 substrates (e.g. dihydroergotamine, ergotamine, fentanyl, cyclosporine, sirolimus, tacrolimus). Ibrutinib is a weak CYP2B6 inducer and may affect expression of other enzymes and transporters regulated via the constitutive androstane receptor (CAR),(e.g. CYP2C9, CYP2C19, UGT1A1, MRP2). Exposure to substrates of CYP2B6 (e.g. efavirenz, bupropion) and co -regulated enzymes may be reduced with ibrutinib. Refer to SmPC for full details of interactions. LEGAL CATEGORY: Prescription only medicine PRESENTATIONS

PACK SIZES

MARKETING AUTHORISATION NUMBER(S)

Bottles

90 capsules

EU/1/14/945/001

Bottles

120 capsules

EU/1/14/945/002

MARKETING AUTHORISATION HOLDER: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium FURTHER INFORMATION IS AVAILABLE FROM: JanssenCilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG UK. Prescribing information last revised: August 2016 Date of preparation: September 2016. PHIR/IBR/0816/0011(1) Adverse events should be reported. This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse events related to this medicinal product. Healthcare professionals are asked to report any suspected adverse events via: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www. hpra.ie, E-mail: medsafety@hpra.ie Adverse events should also be reported to Janssen-Cilag Limited on +44 1494 567447 or at dsafety@its.jnj.com. © Janssen-Cilag Limited 2016

IMBRUVICA® is co-developed with Pharmacyclics. Janssen-Cilag Limited is the marketing authorisation holder and responsible editor of this document.

@JanssenIE © Pharmacyclics LLC 2016


Professional 100 Developing a First-of-its Kind Inhaler Professor Anne Marie Healy has this year been awarded ¤600,000 in funding as part of an ¤8.8 million international project aimed at developing a first-of-its-kind inhaler for the treatment of lung disease. The funding is to be used to develop a new dry powder inhaler that uses novel carbohydrate-based compounds for the treatment of patients with cystic fibrosis, asthma and chronic obstructive pulmonary disease. Anne Marie Healy is a Professor in Pharmaceutics and Pharmaceutical Technology in the School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin (TCD) and is currently Head of School. Professor Healy has over 70 peer reviewed publications; she has given over 100 presentations at national and international conferences, graduated 15 PhD students and mentored 15 postdoctoral researchers.

Professor Anne Marie Healy, Head of School of Pharmacy, TCD

Directing Clinical Trials for RCSI Professor Bryan Hennessy was recently appointed as clinical lead of Cancer Trials Ireland (formerly ICORG). He is an international leader in the application of reverse phase protein arrays (RPPA) for quantitative protein profiling to interrogate predictive and prognostic markers in breast, colon and other cancers, and has established this technology at RCSI. He will lead a trial to test a new treatment for patients with advanced breast cancer which has not responded to currently available treatments. The trial will test for the first time the use of the new drug copanlisib in combination with trastuzumab to treat advanced HER2-positive (HER2+) breast cancer which has progressed or recurred in patients during or following standard anti-HER2 treatment. Professor Bryan Hennessy, Senior Lecturer, RCSI/Consultant Medical Oncologist Beaumont Hospital

Excellence in Psychology Professor Anne Hickey is Head of the Department of Psychology with the RCSI. She is involved in co-ordinating and teaching health psychology to health professionals at undergraduate and postgraduate level, including medical, physiotherapy and pharmacy students. Professor Hickey has considerable expertise in the area of method development and, as part of a research team, developed the Schedule for the Evaluation of Individual Quality of Life (SEIQoL), an individualised measure of quality of life that has received international acclaim and is now being used to assess quality of life, particularly in patient populations, across the five continents. Professor Hickey is Director of the SPHeRE (Structured Population and Health-services Research Education) Programme, a National structured PhD training programme in population health and health-services research.

Professor Anne Hickey, Head of Department, Psychology, RCSI

Lobbying for Hospital Care Leading Sligo Consultant in Emergency Medicine, Mr Fergal Hickey this year came out to lobby the HSE on hospital overcrowding. He says hundreds of elderly patients are needlessly dying due to hospital overcrowding. In a statement issued in the wake of Budget 2017, Mr Hickey of the Irish Association for Emergency Medicine said: "On the day of Budget 2017 a total of 438 patients languished on trolleys in Ireland's Acute Hospitals, 352 of these in the country's 29 Emergency Departments (EDs). Professor Fergal Hickey, Emergency Medicine Consultant, Sligo University Hospital

Real-World Insights Apply real-world data across functions and geographies to meet multi-stakeholder demands.


Professional 100 Chair of Surgery Professor Hill is Professor and Chair of Surgery in the RCSI. He graduated from UCD and did his basic surgical training in Dublin, and his middle grade surgical training in London. He did a basic two year fellowship with Dr John Daly at The Hospital of the University of Pennsylvania and The New York Hospital/Cornell Medical Center in the United States. He returned to Ireland to do his Senior Registrar training on the National Training Program in Ireland.

Professor Arnold Hill, Chair of Surgery, RCSI

He also did a Clinical Fellowship in Surgical Oncology at Memorial Sloan Kettering Cancer Centre in New York prior to taking up his consultant appointment. His clinical interests are in the area of breast cancer and melanoma. His laboratory research interest are in the transcriptional control of breast cancer in particular the role of the coregulatory proteins.

Collaborating with Understanding Chief Executive of Our Lady’s Hospice & Care Services, Ms Audrey Houlihan was a key driving component in a Memorandum of Understanding (MOU) between Our Lady’s Hospice & Care Services and Trinity College Dublin, formalising an academic link between the two. This formal commitment to teaching, research and clinical links provides an opportunity for hospice staff and Trinity students and promotes excellence in patient care and is set to offer many benefits to the future multidisciplinary education programmes at OLH&CS, encouraging greater opportunity for research projects across the organisations and will provide additional opportunities for the education of pharmacists in the care specialties offered at OLH&CS and for the professional development of pharmacy staff.

Ms Audrey Houlihan, Chief Executive, Our Lady’s Hospice & Care Services

Excellence North and South Professor Patrick Johnston received his medical degree with distinction from University College Dublin in 1982, followed by his MD and PhD in Medicine in 1988 and 1995 respectively. He joined the National Cancer Institute (NCI USA) in 1987 where he pursued further clinical training in medical oncology and his doctoral studies. In 1997 he moved to Queen’s University Belfast as Professor of Oncology and became Director of the Centre for Cancer Research and Cell Biology in 2004.

Professor Patrick Johnston, President and Vice Chancellor, Queens University Belfast

He was appointed Dean of the Medical School at Queen’s University in 2007, leading the development of an International School of Medicine, Dentistry and Biomedical Sciences and the Institute of Health Sciences. He took up his current position as President and Vice-Chancellor of Queen’s University on March 1st, 2014.

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Professional 100 Cohort Studies of Vascular Factors Professor Rose Anne Kenny’s primary interest is in the field of research into cardiovascular and mobility disorders in ageing. The overarching aims of the research programmes are to unpick the mechanisms for cardiovascular and cerebral dysfunction in the context of falls, blackouts, cognitive impairment and dementia. Professor Kenny’s research involves collaborative partnership with disciplines from basic science through to health service development and implementation. She has conducted longitudinal cohort studies of vascular factors in cognitive impairment (post stroke cohort, NCVI in the community, and carotid sinus hypersensitivity cohort). She has represented her field on international groups for heart failure, syncope and falls and recently co-chaired the International Panel of experts for “clinical practice guidelines for the investigation and management of falls in older adults” by invitation of the American Geriatrics Society. Professor Rose Anne Kenny, Head, Medicaal Gerontology, St James’s Hospital

Author of National Cancer Strategy Professor John Kennedy, who is a Consultant Oncologist in St James’ Hospital, Dublin, was Chair of the team that developed the soon-to-be-published new National Cancer Strategy. He currently holds the position of Consultant Medical Oncologist at St. James’s Hospital and St. Luke’s Hospital and is Clinical Professor of Medicine in the University of Dublin, Trinity College. Prof Kennedy is a Fellow of the Royal College of Physicians of Ireland, immediate past Chairman of the Medical Board of St James’s Hospital, past Chairman of the All Ireland Cooperative Oncology Research Group (ICORG), a past Chairman of the Irish Society for Medical Oncology (ISMO), a previous member of the boards of St Lukes Hospital and of ARC and is currently Chairman of the board of the Irish Cancer Society.

Professor John Kennedy, Consultant Oncologist, St James’s Hospital

Medicines Reconciliation Service Maríosa Kieran is the Clinical Pharmacy Service Manager in the MMUH. This role involves management of the Pharmacy Department involvement at ward level, personnel management, hospital and departmental project work and service development. Maríosa is also a honorary lecturer in RCSI. In 2016 she has managed the introduction of a Medicines Reconciliation Service to the MMUH which has seen the MMUH adopting WHO guidance for Medicines Reconciliation Services. She has also redesigned the training and induction for clinical pharmacists to the MMUH. Maríosa was one of four HPAI members selected to represent the HPAI at the European Association of Hospital Academy Seminars in 2015 and 2016.

Mariosa Kieran, Clinical Pharmacy Services Manager, Mater Misericoridiae University Hospital

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Professional 100

Relocating a New Aseptic Unit Deirdre is the team lead of the Aseptic Compounding Team of the MMUH and has in the last 12 months been responsible for introducing electronic prescribing alongside assisting with the designing/relocation to a new aseptic compounding unit. She has also been responsible for validation of gravimetric chemotherapy compounding. he introduction, by the MMUH, of the first fully integrated system for prescribing, manufacture and administration of chemotherapy across the Oncology and Haematology Services in Ireland represents a forward thinking, dynamic and innovative aseptic compounding unit.

Deirdre Lenehan, Drug Safety Facilitator, Mater Misericordiae University Hospital

Establishing a Rare Kidney Disease Network Professor Mark Little, Clinician Scientist/Consultant Nephrologist, Tallaght Hospital

Professor Little is currently engaged in major research projects on vasculitis, including the establishment of an Irish Rare Kidney Disease (RKD) Registry and Biobank. He has already led the development of a RKD biobank and registry, which is co-ordinated through Tallaght Hospital. It currently receives biolgocial samples from five centres across Ireland and has become one of the most important bio-resources in this field globally. Professor Mark Little is a Clinician Scientist with experience of international academic leadership in the field of autoimmune kidney disease. He is a Consultant Nephrologist based in Tallaght Hospital and Trinity College Dublin. He runs a translational medicine research programme focused on investigation of pathogenesis and discovery of biomarkers of disease in glomerulonephritis.

Building on Existing Research Programmes Dr Graham Love is the Chief Executive of Molecular Medicine Ireland (MMI). Dr Loveâ&#x20AC;&#x2122;s expertise has helped MMI to build on existing collaborative programmes to increase Irelandâ&#x20AC;&#x2122;s capacity in clinical and translational research and benefit healthcare and the economy. This year he has been instrumental in driving the clinical and translational research agenda at the heart of MMI. Dr Love believes that bridging research and improved health outcomes via its partner institutions and teaching hospitals is a great opportunity for Ireland. Dr Love has held a number of senior management roles at SFI including Interim Director General, Special Advisor to the Director General, Head of Strategy and Programme Implementation. Dr Love graduated with a BSc (Hons) in Pharmacology from University College Dublin followed by a PhD in Vascular Cell Biology in 1997. Graham Love, Chief Executive, Molecular Medicine Ireland

Transform Clinical Development Pave a more precise and predictable path to product approval and beyond.


Professional 100 Founding the Genome Stability Laboratory Professor Lowndes is Chair of Biochemistry at NUI Galway. He founded the Genome Stability Laboratory, which focuses on the mechanisms of sensing and responding to DNA damage using yeast and vertebrate cells. He is an expert on the mechanisms of cell cycle control and the DNA damage-response, a thorough understanding of which will translate into improved cancer diagnosis and therapeutic regimes. More specifically, the two major areas of current focus are the function and regulation of checkpoint mediators (Rad9/53BP1) and PIK kinases, (Mec1/ATR and ATM). A recent study Prof Lowndes led found that the anti-cancer gene TP53 has more tools to fight cancer than previously thought. The anti-cancer gene had previously been identified for its processes which prevent cancer cells from multiplying in the body.

Professor Noel Lowndes, Chair of Biochemistry, NUI Galway

Developing Clinical Care for Neurology As Clinical Lead of the National Clinical Programme of Neurology, Professor Lynch developed a new comprehensive model of care for the programme, which was published in October 2016.Professor Tim Lynch is Consultant Neurologist at the Mater Misericordiae University Hospital and Beaumont Hospital, UCD Full Clinical Professor at the UCD School of Medicine and Director of the Dublin Neurological Institute. The “Model of Care for the National Clinical Programme of Neurology” aims to define the future set up of acute and chronic neurological services in Ireland. Prof Lynch is a Royal College of Surgeons medical graduate from 1984 and a UCD BSc Pharmacology graduate from 1986.

Professor Tim Lynch, Consultant Neurologist, Mater Misericordiae University Hospital

National Head for Hospital Technicians

Laura Lyons, President, National Association Hospital Pharmacy Technicians

Laura is a Senior Pharmacy Technician in the Mater Misericordiae University Hospital with responsibility for purchasing. Laura has always been an active Hospital Pharmaceutical Technician on a national level, becoming a member of the National Association of Hospital Pharmaceutical Technicians (NAHPT) Committee in 2007. She embarked on the NAPHT newsletter editor’s role in early 2011, co-ordinating articles for the newsletter which is distributed nationally approximately three times a year. In addition to her editor’s role, Laura became NAHPT Vice President in 2012. Laura became the NAHPT President in 2014. As well as providing leadership for pharmacy technicians this role entails many responsibilities including organisation of the annual NAHPT conference.

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Professional 100 Polypharmacy Commonplace amongst Older Adults Professor Mary McCarron is the Principal Investigator for IDS-TILDA and Dean of the Faculty of Health Sciences. This year, new findings from Trinity College Dublin’s IDS-TILDA study highlighted that polypharmacy is commonplace among older adults with intellectual disabilities. This is the first time there has been a comprehensive review of medicines use in people with intellectual disabilities, and particularly older people with intellectual disabilities in Ireland,” she says. “The longitudinal nature of our study will allow us to provide a comprehensive insight into changes in medication patterns as people with intellectual disability age and move into community settings and will enable us to examine the effect of multiple medicines on health outcomes and quality of life.” Professor Mary McCarron, Professor of Ageing & Intellectual Disabilities (School of Nursing & Midwifery) and Dean of Health Sciences

A Leading Force in Cardiology Care Professor Ken McDonald is Consultant Cardiologist in St Vincent’s University Hospital Dublin and HSE Clinical Lead of the National Heart Failure Programme. Professor McDonald developed the St Vincent's Chronic Cardiovascular Disease Management Unit incorporating the Heart Failure Unit and Blood Pressure Unit following his return from the Minnesota, US. He has overseen the growth of the Unit into an internationally recognised clinical service and translational cardiovascular research centre.

Professor Ken McDonald, Consultant Cardiologist, St Vincent’s University Hospital

In addition, Professor McDonald developed the St Vincent's Screening To Prevent Heart Failure (STOPHF) Programme in association with St. Vincent's Collaborative General Practice Group. The STOP-HF study is first-of-type, pragmatic, prospective trial which showed that natriuretic peptide-based screening and collaborative care can reduce the combined rate of left ventricular dysfunction and heart failure as well as major adverse cardiac events.

Global Publication in Cystic Fibrosis Professor Gerry McElvaney has a strong track record in translational research and has published widely in the areas of cystic fibrosis (CF), alpha-1 antitrypsin deficiency (AATD), infection, immunity, and lung inflammation. Under his directorship the Respiratory Research Division has attracted national and international funding, including grants from the Health Research Board, Science Foundation Ireland, The Higher Education Authority, The CF Association of Ireland, and the US Alpha-1 Foundation. His unit has a well-established track record in research into CF and AATD and their work on lung defenses has led to interactions with pharmaceutical companies interested in translational research.

Professor Gerry McElvaney, Cystic Fibrosis Specialist

Tackling Stroke in Ireland Dr Kate McGarry, President, Irish Heart Foundation/ Consultant in General Internal Medicine

Dr Kathleen (Kate) McGarry is President of the Irish Heart Foundation. In taking up this new appointment earlier this year, Dr McGarry set out to help deliver the organisation’s life-changing and life-saving services to more people affected by heart disease and stroke in Ireland. The IHF is at the forefront in educating the public about cardiovascular diseases and about how to manage risk through lifestyle changes. It is currently lobbying the Government on the National Obesity Plan and the National Physical Activity Plan. Dr McGarry has a wealth of experience and as a champion of non-invasive treatment for heart patients. She is a consultant in General Internal Medicine (GIM) with a specialty interest in non-invasive Cardiology and a renowned figure in the northeast where she was a Consultant Physician in Our Lady's Hospital, Navan from 1983 until 2014.

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Professional 100 Bill at the Helm of Bon Secours Bill Maher established the first Hospital Group in the country – Saolta Healthcare Group CEO. The Hospital Group was established to deliver improved performance and effectiveness in the safe delivery of acute hospital services as the first step in the formation of a Hospital Trust as part of the Government’s reform of the health service. Mr Maher was currently Chief Executive of the Royal College of Surgeons Ireland (RCSI) Hospital Group and has over 20 years' experience at senior management level in healthcare both in Ireland and the U.K. Mr. Maher's skills and experience will ensure the continued growth and success of the Bon Secours Health System nationally. Mr Bill Maher, CEO, Bon Secours Hospital Group

Developing Understanding in Mental Health Mr Tom Maher led St Patrick’s University Hospital through the formation of two academic partnerships this year. The latter was a Memorandum of Understanding between the Pharmacy Department at St Patrick’s Mental Health Services and Trinity College Dublin, signed in November of this year. This Memorandum will enable St Patrick’s Pharmacy and TCD to formally establish teaching, research, and clinical links; facilitate professional development in pharmacy; encourage research, and, work together for the provision of excellence in patient care. Earlier this year, in April, St Patrick’s Mental Health Services established a formal agreement that will enable the Hospital to grant clinical facilities and facilitate the clinical training of undergraduate medical students from the Royal College of Surgeons in Ireland (RCSI). Mr Tom Maher, Director of Services, St Patrick’s University Hospital

Dean’s Award 2016 for Celine Professor Celine Marmion was this year named as the 2016 winner of the RCSI Dean's Award. The Dean's Award scheme was created as a way of acknowledging the diverse and essential contributions of all staff members at RCSI. Both winners were presented with a commemorative award by Professor Hannah McGee, Dean of the Faculty of Medicine and Health Sciences. As an educator, Professor Marmion is deeply committed to nurturing excellence in the education, learning and assessment of students. She was the recipient of a 'Teaching Hero' award in 2016 (as voted by students). This is a national award presented by the National Forum for the Enhancement of Teaching and Learning in Higher Education in partnership with the Union of Students in Ireland. Professor Celine Marmion, Associate Professor, Department of Pharmaceutical & Medicinal Chemistry

Making Asthma Personal Campaign Launch In 2016 Professor Pat Manning launched the ‘Make Asthma Personal’ campaign alongside the HSE and Asthma Society of Ireland. Prof. Manning qualified from the Medical School of Royal College of Surgeons (Ireland) and following Internal Medicine Training in Ireland, completed his specialist training in Adult Respiratory / Sleep Medicine at McMaster University in Canada. He then undertook research in asthma and allergy with a particular focus on the role of histamine and leukotrienes in allergic and exercise induced-asthma with Prof Paul O’Byrne in Canada and has published widely in this area in National and International Journals and continues to do so.

Professor Pat Manning, Consultant Respiratory Physician & HSE Lead for the National Clinical Programme for Asthma

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Professional 100 Evolving Hospital Pharmacy Agenda Professor Ciaran Meegan continues to lead one of the most innovative and evolving Pharmacy Departments in the country. While Ciaran has always had an eye to the progression of the profession nationally, he has also always worked tirelessly with his own staff in the Mater Hospital, ensuring the Department has kept within the financial constraints imposed, expanding and evolving services in line with national and international practice.

Professor Ciaran Meegan, Head of Pharmacy Services, Mater Misericordiae University Hospital

Research Bursary for Dr Mitchell Dr Patrick Mitchell from St Vincent's University Hospital, Dublin was this year awarded The Asthma Society of Ireland - Irish Thoracic Society Joint Research Bursary. He was awarded this for his research into the role of IL-33 and its receptor and GLP-1 and its receptor on eosinophils in a mild allergic cohort following a bronchial allergen challenge. Dr Mitchell, is currently undertaking a two year clinical and research fellowship at McMaster University, Canada, under the mentorship of Professor Paul O’Byrne. He is currently investigating whether two particular types of pathways play a role in asthma chronicity and flare-ups. One of these pathways has been established as playing a role in allergic diseases but how it changes during a flare-up of asthma is essentially unknown.

Dr Patrick Mitchell, St Vincent’s University Hospital,, Dublin

HPN Hospital Specialist of the Year 2016 Sarah Molony completed an MSc in Hospital Pharmacy in 2015 incorporating research on The treatment of hypoglycaemic events in the MMUH – improving the safety of diabetic patients winning the Hospital Pharmacists Association of Ireland Audit Poster Award 2016. Winner of the HPN Hospital Specialist of the Year Award 2016 for her work in developing a video for distribution to community pharmacist colleagues on the manufacturing of extemporaneous eye drops. This project was short-listed for presentation at the Hospital Pharmacists Association of Ireland Conference 2016. Sarah Molony, Deputy Clinical Pharmacy Services Manager

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Professional 100 Red, Amber, Green, for Prof Morris Earlier in 2016, scientists at AMBER Ireland developed a process to make new bones using 3D bioprinting technology. The development could lead to new methods for large and complex defects in bones to be repaired - replacing the need for bone grafts. More than two million people globally need a bone graft each year to repair problems caused by conditions like tumour removal, infection, injury and inherited deformities. A leading academic and industry scientist for thirty years, Professor Morris is also founder of Glantreo, an SME spin out company from University College Cork, and maintains links with the company in developing novel stationary phase materials for chromatography applications.

Professor Michael Morris, Director, AMBER Research Centre

Building Strong Foundations for Science Dr Darrin Morrissey was appointed SFI Director of Programmes in September 2014, joining SFI from Stiefel, a GlaxoSmithKline (GSK)-owned company that develops and manufactures dermatology products. At Stiefel, he held the role of Business Improvement Director and was responsible for leading strategy deployment, change management and business transformation. Darrin originally joined GSK in 2007 as Head of Oncology for Ireland and led the establishment of GSKâ&#x20AC;&#x2122;s oncology business and the launch of its oncology and haematology therapeutics portfolio. During his time with GSK Darrin also held the role of Global Oncology Marketing Director with responsibility for developing launch strategy for melanoma therapy assets.

Dr Darrin Morrissey, Director of Programmes, Science Foundation Ireland

Leading Cancer Trials in Ireland Eibhlin Mulroe was appointed CEO of Cancer Trials Ireland (then ICORG) in June 2015. Since then she has led an extensive rebranding and programme of change designed to strengthen the organisationâ&#x20AC;&#x2122;s governance and oversight structures, enable it meet best international practice standards, facilitate the next stage in its growth and maximise the benefits cancer trials can deliver to Irish patients. Building on her many years as a patient champion (as CEO of the Asthma Society of Ireland and more recently as CEO of IPPOSI) this change programme has been underpinned by active engagement with external stakeholders and particularly patients to empower them to become actively involved in cancer trials research decision making.

Eibhlin Mulroe, CEO Cancer Trials Ireland

HPN Young Hospital Professional of the Year Dearbhla won HPN Young professional of the Year 2016. In July 2015, the MMUH introduced electronic prescribing for chemotherapy. Following the implementation of this new software Dearbhla designed and conducted a research study investigating the rate of prescribing errors and omissions using handwritten versus electronic prescriptions. Dearbhla was awarded an Education Bursary for this work at the 2016 Irish Society of Medical Oncology Meeting. Dearbhla was also selected to present her project at the 2016 HPAI annual conference and her research will be presented at the BOPA 2016 conference.

Dearbhla Murphy, Aseptic Compounding Pharmacist

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Professional 100 Actavis Innovation in Aseptic Award Winner Joanne has worked as a Senior Pharmacist in the Aseptic Compounding Unit in the University Hospital Limerick for the past five years and prior to that she worked as a Senior Clinical Pharmacist for the hospital since 2006. She has excelled in her role, undertaking roles and responsibilities associated with Oncology Pharmacy and is seen by her colleagues as a true role model in her attitude, energy and enthusiasm to her work. She plays a pivotal role in pharmacy operations in the A.C.U ensuring the clinical pharmacy service adequately meets the needs of staff and patients, managing dispensary operations, clinically checking and verifying Chemotherapy prescriptions and developing chemotherapy protocols on the hospitals e-prescribing system.

Joanne Nally, Oncology Pharmacist, University Hospital Limerick

Driving Force Behind HPRA Dr Lorraine Nolan is a chemist having completed her Ph.D. and post-doctoral research at Trinity College Dublin in transdermal drug delivery. She worked for a number of years in private industry in the area of enhancing and developing drug delivery systems, and also within the state forensic science services. Ms Nolan joined the HPRA in 2001 and since that time has held a number of different roles at senior level within the organisation across a range of areas including inspection and authorisation of human medicines, medical devices, cosmetics and controlled substances. Prior to assuming the role of Chief Executive she was Director of Human Products Authorisation & Registration. Dr Nolan is a member of the Management Board of the European Medicines Agency. Dr Lorraine Nolan, Chief Executive, Health Products and Regulatory Authority

Biosimilars to the Fore Joan O’Callaghan is based in HPRA and has been in her current role as a Research Scientist for Regulatory Science Ireland (RSI) since January 2016. RSI is a network of interested parties from Academia, Health Products Regulatory Authority (HPRA), Pharmaceutical Industry, Medical Devices Industry and Government Agencies. HPRA together with UCC have established a RSI project to conduct research on the public health impact of the increased use of biosimilar medicines. Joan is lead researcher on this project. Joan graduated with an Honours degree in Pharmacy from Trinity College Dublin (TCD). Upon completion of her degree she undertook her pre-registration training at St. James’s Hospital, Dublin.

Joan O’Callaghan, Research Scientist, Regulatory Science Ireland

HPN Consultant Led Team of the Year Winner The lung transplant team in the Mater Misericordiae University Hospital celebrated a record year in 2015. Not only were a record number of lung transplants performed, but a number of other “firsts” were achieved by the team, the first heart-lung transplant and the first Irish EVLP transplant. Dr O’Connell led the team to winning the HPN Consultant-Led Hospital Team of the Year Award 2016. Dr Oisin O’Connell, Respiratory/Transplantation Consultant

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Professional 100 Medisource Hospital Pharmacy Technician of the Year Leonor O Connor recently won the title of Hospital Pharmacy Technician of the Year 2016. She has been working in the Pharmacy in St James's Hospital for the last 14 years. She constantly motivates her colleagues and is continuously working to improve the role of the pharmacy technician within SJH and also through her volunteer work with the NAHPT. Leonor has been working at St James’s Hospital for the last 14 years. During this time she has aided in the enhancement of the role of a pharmacy technician within the hospital. She is described as someone who has always been welcoming, helpful and a hard working person. Leonor O’Connor, Senior Hospital Pharmacy Technician, St James’s Hospital

Saving the State on Medicines Pricing

Mr O’Connor headed up negotiations between IPHA and the HSE which this year led to a new pricing Agreement, finalised in July. Just last month it was revealed that this agreement is on course to save the State over ¤140 million in its first year. Following an analysis of the 948 separate product price changes as listed by the HSE, IPHA is confirming the annual total value of the price reductions since August 1st across all of the IPHA products is on track to provide savings of ¤78.4m annually. A former Special Advisor in the Irish Government, 2001-2010, for Ms Mary Harney, he was central to key initiatives such as the National Treatment Purchase Fund.

Mr Oliver O’Connor, Chief Executive, IPHA

Increasing Insurance Membership In 2016, Vhi announced its annual results recording a net surplus of ¤45.5 million and an improved reserves position of ¤521 million at year end. They have also recorded an increase in membership for the first time in 8 years and is now serving 1.068 million health insurance customers. John O'Dwyer joined Vhi Healthcare in August 2012 from the international Dutch insurance group Achmea where he was the Chief Operating Officer and Executive Director with responsibility for the life, general and health businesses in Interamerican, the second biggest insurer in Greece. John has an extensive track record in financial services and, in particular, the health insurance sector. He was also non-executive Chairman of the Board of the National Treatment Purchase Fund. John O’Dwyer, Chief Executive, Vhi

Leading the Blood Cancer Network Professor Michael O’Dwyer is Professor of Haematology, NUI Galway and Consultant Haematologist at University Hospital Galway. He heads the recently established Blood Cancer Network Ireland (BCNI), which is a collaborative network of clinicians, scientists, and population health experts across Galway, Cork and Dublin with a shared interest in blood cancer research. Professor Michael O’Dwyer, Professor of Haematology, NUI Galway

BCNI will provide blood cancer patients in Ireland with the opportunity to be among the first in the world to test new, potentially life-changing, drugs and treatments through early stage clinical trials.

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Professional 100 Planets of Change for Telemedicine Dr Marc Ó Gríofa recently participated in the NASA Extreme Environment Mission Operations 21 (NEEMO 21 Mission) living with the other five researchers for eight days in simulated space-craft conditions under the Atlantic Oceans to test out new techniques, technologies and procedures in preparation for future missions either to an asteroid or going to the surface of Mars. Dr Ó Griofa used the opportunity to highlight the ongoing contribution of Irish science to space exploration and participated via video link from the bottom of the ocean to Irish research collaborators and students. Dr Marc Ó Gríofa studied Medicine at University College Dublin graduating in 2006. His research mainly focuses on a combination of telemedicine technology and telomere genetics research.

Dr Marc Ó Gríofa, NASA Extreme Environment Missions Operations 21

World Authority on Immunity

Professor Luke O’Neill, Chair of Biochemistry, Trinity College Dublin

Professor Luke O’Neill is Professor of Biochemistry, Trinity College Dublin, where he leads an 18 member research team working on the molecular basis to inflammation and inflammatory diseases. He is a world authority on innate immunity, which lies at the heart of inflammation, with a particular interest in Toll-like receptors, inflammasomes and metabolic reprogramming. He was awarded the Royal Dublin Society / Irish Times Boyle Medal for scientific excellence in 2009, the Royal Irish Academy Gold Medal for Life Sciences in 2012 and the European Federation of Immunology Societies Medal in 2014. Thompson Reuters have listed him as being one of the world’s most influential scientists, ranking in the top 1% of scientists working in the areas of immunology and pharmacology.

From Cancer Programmes to Dublin Midlands Dr Susan O’Reilly was appointed as the CEO of the new Dublin Midlands Hospital Group in November 2014. Previously, she was the Director of the National Cancer Control Programme (NCCP), Ireland, in September 2010. She lead the planning and implementation of the National Strategy for Cancer Control in Ireland, across the spectrum of prevention, screening programmes, Surgical Oncology, Radiation Oncology and Medical Oncology, as well as the development of national treatment guidelines and performance management. Dr O’Reilly qualified in medicine at Trinity College, Dublin, and completed postgraduate training in Internal Medicine at Trinity College and University College Dublin.

Dr Susan O’Reilly, CEO, Dublin Midlands Hospital Group

Principal Investigator in Obesity

Professor Donal O’Shea, Consultant Endocrinologist, St Vincent’s University Hospital/ St Columcille’s Hospital

Professor Donal O'Shea is a Consultant Endocrinologist and physician based in St Vincent’s University Hospital and St Columcille’s Hospital. He is the principle investigator in a research group that currently focuses on the study of the health consequences of obesity. Prof O’Shea was a lead author of new groundbreaking research involving a team of Irish, American and Canadian researchers reveals that the immune system could be responsible for as much as 40 per cent of the body’s ability to regulate weight. Prof O’Shea qualified from University College Dublin in 1989. He moved to Hammersmith Hospital in London and worked as a Registrar in General Medicine, Cardiology and Endocrinology before being appointed as Senior Registrar in the Department of Diabetes and Endocrinology.

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Professional 100 President of European Hospital Pharmacists Joan is Chief Pharmacist in Tullamore hospital and President of the European Association of Hospital Pharmacy, elected in 2015. As president of EAHP she represents 21,000 pharmacists in 35 countries at the international level. She is involved in numerous European issues including a pan European group looking at medicines shortages and overseeing annual surveys of European Hospital Pharmacy practice. For 2016 a new strategy to support implementation of the European Statements of Hospital Pharmacy and the development of a common training framework for recognition of hospital pharmacy as a specialisation are top priorities described on www.eahp.eu She has been instrumental in the establishment of many national initiatives within pharmacy, such as the annual clinical skills course for Hospital Pharmacists and the establishment of antimicrobial pharmacist posts at a national level.

Joan Peppard, President, European Association Hospital Pharmacists, Chief I Pharmacist, Tullamore Hospital

MSD Antimicrobial Pharmacist of the Year Marie Philbin has been the Antimicrobial Pharmacist in Midland Regional Hospital Tullamore (MRHT) since 2004 and is the longest serving in this role in Ireland. Marie’s initial work in MRHT demonstrated significant cost savings, a trend from broad spectrum to narrow spectrum agents and an accompanying reduction in Clostridium difficile infection. This work was the stimulus for the HSE creation of 20 Antimicrobial Pharmacist positions in hospitals around the country. This initial work also won Marie the Servier award bursary of ¤3,500 at the HPAI annual conference in 2005. Marie’s work in MRHT initially involved audit and feedback, education and bedside patient review.

Marie Philbin, Antimicrobial Pharmacist, Midland Regional Hospital, Tullamore

Translational Research Access Grant Dr Power's interests include melanoma, gastrointestinal and genitourinary cancers, as well as familial cancer genetics. He has given oral presentations at the ASCO and ESMO meetings and is a member of national and international cancer organisations. Dr Power is the recipient of a translational research access programme application grant from UCC for 'Neuroendocrine and gut microbiome biomarkers in pancreatic cancer cachexia' and has received investigator-initiated funding on kidney cancer, colorectal cancer and melanoma studies. One such funded study is 'The use of electrochemotherapy in combination with immunotherapy in advanced melanoma.' This trial is led by Dr Power in conjunction with the Cork Cancer Research Centre. Dr Derek Power, Consultant Medical Oncologist, Mercy University Hospital

Taking Corporate Plans to Reality The Health Information and Quality Authority (HIQA) launched their corporate plan this year and a Draft National Standards for Safer Better Maternity Services. In line with this new Corporate Plan 2016–2018, HIQA continue to focus on improving children and adults’ rights and their experience of care. HIQA are also committed to further advancing strategic improvements in Ireland’s health system through the development of national standards and the eHealth agenda, as well as developing their health technology assessment (HTA) function. Mr Quinn was appointed Chief Executive on 26 November 2014. He joined HIQA as Director of Regulation and chief inspector of social services on 1 November 2012.

Mr Phelim Quinn, Chief Executive, Health Information and Quality Authority

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Professional 100 Society Medal for Cardiothoracic Surgery Ms Redmond and her team in the Mater recently have performed an innovative new lung transplant procedure on a woman with cystic fibrosis. She specialises in the surgical management of patients with lung cancer, end-stage lung disease, and a range of other prevalent conditions such as pneumothorax, pleural effusion, airway obstruction and chest wall abnormalities. Ms Redmond was awarded an honours degree with the Gold Medal in Surgery from University College Dublin in 1997. The first female lung transplant surgeon to be appointed both in the UK and Ireland, Ms Redmond returned from her consultant post at The Royal Brompton Harefield NHS Trust and Imperial College in London in 2011.

Ms Karen Redmond, Consultant Thoracic and Lung Transplant Surgeon

Acquiring New Portfolios for Pfizer 2016 has been a busy year for Pfizer Managing Director Paul Reid. In the last 12 months, they have acquired Anacor, which will bring the company new medicines, and they have also acquired Hospira, which means that can bring into play, a force biosimilar medicines. They are also pending a final acquisition of Medivation, which will bring in an oncology portfolio, and particularly prostate medicine, which will beef up Pfizer’s oncology presence for the future. Pfizer continues to bring many leading medicines in areas such as arthritis, cancer, cardiovascular health, pain and vaccines. They continue to be one of the leading employers with over 3,000 colleagues, and seven sites in Ireland. Mr Paul Reid, Managing Director, Pfizer

Cooking Up a Storm Dr Aoife Ryan was one of the team members behind the launch in 2016 of a cookbook for cancer patients experiencing difficulties in chewing or swallowing their food. The book, ‘Eating Well with swallowing difficulties in cancer,’ was launched by University College Cork (UCC) and Breakthrough Cancer Research. The recipes contained within the cookbook are simple, nourishing and enjoyable, more importantly, all of the recipes are easy to chew, swallow and were created specifically for patients who are losing weight.

Dr Aoife Ryan, Lecturer In Nutritional Sciences, UCC

Managing Surgical Affairs

Mr Kieran Ryan, Managing Director of Surgical Affairs, RCSI

Mr Kieran Ryan joined the RCSI this year as the College’s new Managing Director of Surgical Affairs. Mr Ryan moved to RCSI from his previous position of Chief Executive Officer of the Irish College of General Practitioners, a post he has held since 2011. Prior to this Mr Ryan worked with the RCSI Department of Surgical Affairs as Research Manager and then Associate Director. As Director of Clinical Services at Hermitage Medical Clinic he has gained significant experience in setting up a modern, high-tech hospital. He previously worked as Implementation Executive with the Irish Health Services Accreditation Board, Good Clinical Practice Inspector with the Irish Medicines Board and as Clinical Trials Manager with GlaxoSmithKline Ireland.

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Professional 100 President of Hospital Consultants Dr Tom Ryan, Consultant in Intensive Care and Anaesthesia, St James’s Hospital, Dublin, was elected President of the Association earlier this year. Dr Ryan takes over the Presidency from Dr Gerard Crotty, who had completed his two year term. Dr Ryan has been a Consultant in Intensive Care and Anesthesia since 1997. He began his training in Ireland, followed by sub-specialty training at the University of Washington in the US. He undertook additional Intensive Care and Anaesthesia training at the Mayo Clinic in Minnesota and was a Consultant in the Cleveland Clinic, before returning to Ireland to his position in St James’s Hospital.

Dr Tom Ryan, President, Irish Hospital Consultants Association

Founding Member of Hospital Technicians Yvonne Sheehan is a Senior Pharmacy Technician who primarily works in the purchasing area. Yvonne was on the founding committee of the National Association for Hospital Pharmacy Technicians in 1997 and has been actively involved with that committee for 19 years promoting the role and professionalism of hospital pharmacy technicians. Yvonne has also sat on the committee of the European Association for Pharmacy Technicians from 2001-2016. She organised their first congress in Ireland in 2002 and was also part of the organising team for the FIP world pharmacy conference in Dublin in 2012. In 2014 Yvonne was awarded the HPN Hospital Pharmacy Technician of the Year award and in 2016 she was part of the team that won the HPN Hospital Pharmacy Team award, the team developed a Medicines Management Technician service which has been rolled out across the Hospital.

Yvonne Sheehan, Senior Pharmacy Technician, Tallaght Hospital

Establishing an Active Research Unit Dr Diarmuid Smith is one of the top Endocrinologists in the country. He graduated from UCD with an honours medical degree in 1994 and completed the Irish specialist registrar training programme in diabetes, endocrinology and general internal medicine in 2003. He was appointed Lecturer in Endocrinology to St Vincents University Hospital in 2004 and then as a Consultant Endocrinologist to Beaumont Hospital in 2005. Since his appointment to Beaumont Hospital, Dr Smith has established an active research unit with a particular interest in diabetes and vascular disease, diabetes foot disease and hypoglycaemia. At a national level Dr Smith has been the secretary and chair of the diabetes section of the Irish Endocrine Society and the HSE national clinical lead for diabetes. Dr Diarmuid Smith, Consultant Endocrinologist, Beaumont Hospital

CBE for Blood Cancer Work Professor Owen Smith is a Consultant Paediatric Haematologist at Our Lady’s Children’s Hospital Dublin, and is Professor of Haematology at the University of Dublin, Trinity College Dublin. He was recently awarded a CBE for his lifelong work in the field of child and adolescent blood cancers. is active research areas of interest include: childhood and adolescent leukaemias& lymphomas, bone marrow failure syndromes, angiogenesis and haematological malignancies, the molecular and cellular basis of the inflammatory – coagulation interface in human disease.The co-author of more than 300 research original articles, letters, books, book chapters and papers, Professor Smith is a Fellow of the Royal College of Pathologists, the Royal College of Physicians of Dublin, London, Glasgow, Edinburgh and the Royal College of Paediatrics and Child Health.

Professor Owen Smith, Consultant Paediatric Haematologist, Our Lady’s Children’s Hospital

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Professional 100 Leading Author of International Study

Dr Andrew Smyth, Researcher, Health Research Clinical Research Facility

Dr Andrew Smyth is a researcher at the Health Research Clinical Research Facility at NUI Galway and the Population Health Research Institute at McMaster University, Canada. Dr Smyth was the lead author of a recent international study, which found an association (more than twice the risk) between anger or emotional upset and the onset of heart attack symptoms within one hour. The same was true for heavy physical exertion during the hour before their first heart attack. However, the association was stronger (more than triple the risk) in those patients who recalled being angry or emotionally upset while also engaging in heavy physical exertion. Researchers analysed data from 12,461 patients (average age 58) participating in INTERHEART, a study consisting of patients with firstever heart attacks across 52 countries.

Anti-Cancer Gene Therapy Leader Dr Mark Tagney is the Principal Investigator within the Cork Cancer Research Centre, a dedicated cancer research unit within University College Cork and the Mercy University Hospital, where he heads a research team investigating various anti-cancer gene therapies. Dr Tangney has published extensively in the field of cancer gene therapy and microbiology, and is Vice-President of the Irish Society for Gene and Cell Therapy, member of the Executive Committee of the International Society for Cell and Gene Therapy of Cancer, a scientific committee member of the European Society for Gene & Cell Therapy and a member of the editorial board of several international journals.

Dr Mark Tagney, Principal Investigator, Cork Research Centre

A First for Ireland inn Research Award Professor Cormac Taylor this year became the first academic outside the United States to receive the American Physiological Society’s 2016 Takeda Distinguished Research Award. The society’s Gastrointestinal and Liver Physiology section awards the prize annually to an outstanding investigator who is internationally recognised for his/her contribution to research in the area. Professor Taylor leads a research group at the UCD Conway Institute investigating the mechanisms by which epithelial cells – cells on the surface of the skin – respond to low oxygen levels in the body (hypoxia). Professor Cormac Taylor, Professor of Cellular Biology, University College Dublin

Presiding over the Medical Council A cardiothoracic surgeon, Professor Wood has pioneered heart surgery and transplantation in Ireland. From 1999 to 2010 he served as Director of Heart & Lung Transplantation at the Mater Hospital, where Ireland’s first successful lung transplant was carried out in 2005. He is currently in private practice, and is a member of the council of the Royal College of Surgeons in Ireland. - See more at: https://www. medicalcouncil.ie/News-and-Publications/News/2013/Items/Medical-Council-elects-Professor-FreddieWood-as-President.html#sthash.XZ8VidSI.dpuf Professor Freddie Wood, President, Irish Medical Council

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90 Feature

40% Prostate Cancer diagnosis rate in 2015 Over 2,559 men were seen in 2015 in the National Cancer Control Programme Rapid Access Clinics with a total of 1,020 men diagnosed with prostate cancer.

NCCP Director Dr. Jerome Coffey

The fifth National Cancer Control Programme (NCCP) Prostate Cancer Quality and Audit Forum took place at the start of November in Farmleigh House, Dublin. Over 3,400 men are diagnosed with prostate cancer annually in Ireland and this number is expected to increase over the coming decades as Ireland’s population ages. Forty years ago the outlook for a prostate cancer patient was vastly different from today. In 1976, a little over one in three men diagnosed with prostate cancer (35%) survived the disease over five years. Today, five-year survival rates for prostate cancer in Ireland have risen to nine in ten (90.6%). However, more needs to be done to improve survival rates, particularly for men with metastatic prostate cancer, while also working on ways to improve the lives of men surviving the disease who often suffer a reduced quality of life. The November Forum brought together the leading prostate cancer experts from across the country and provided them with an opportunity to review the practices of the Rapid Access Prostate Clinics at each of the eight designated cancer centres to date. It also allowed for a sharing of the latest information on prostate cancer including diagnosis and treatment options. Speaking at the event, NCCP Director Dr Jerome Coffey said, “Our diagnosis rate for prostate cancer is 40% illustrating that GPs are referring patients into the system, which aims to provide diagnosis within a three to four week timeframe.

Professional Top100 - 2016 • HPN

For the majority of men who do not have cancer, this timeframe reduces the anxiety that longer waiting involves. For those men who are diagnosed, their treatment options are discussed and considered by an expert multidisciplinary team to ensure that the patient is given all the options and all the information on the best approach to be taken.” Rapid Access Mr David Galvin, National Prostate Cancer Clinical Lead, added that the rapid access prostate clinics have proved themselves as a ‘highly efficient’ and successful component of the health service. “This year we have been examining ways to expand this service model to other high risk symptoms such as blood in the urine (haematuria),” he said. “Blood in the urine is a serious medical condition and strongly associated with an underlying malignancy. This requires urgent and complete evaluation of the urinary tract which includes imaging of the kidneys and a cystoscopy of the bladder.” Guest speaker this year was Dr Andrew Vickers, a world renowned expert on PSA and

the early detection of prostate cancer. Dr Jerome Coffey confirmed that urological cancers are a priority area for the NCCP in 2017, adding a focus on the further development of national Haematuria Clinics. The NCCP are also launching their new patient booklet, ‘Information for Men on Sexual Wellbeing after Pelvic Cancer Treatment’. This booklet aims to help open the conversation for men about their sexual wellbeing after their pelvic cancer treatment. Pelvic cancer includes cancer of the prostate, bladder, penis testis and rectum. The treatment for each of these cancers can result in some sideeffects. It is important for men and their family to know that side-effects can be managed and minimised and that quality of life can improve. The project board comprises national multidisciplinary cancer teams in conjunction with men’s cancer support groups of the Irish Cancer Society. This patient booklet has been awarded the “Plain English Award” by the National Adult Literacy Agency (NALA). Concluding Dr Jerome Coffey said, “Our Rapid Access Services – for Prostate, Lung and Breast Cancer – have been

a significant focus within the development of cancer services nationally. With all of our clinics now open and operating on a standardised basis, our focus is to ensure that they continue to be managed in a quality assured, consistent basis that ensures that, regardless of where any of our patients live, they will access the same service, delivered in the same manner by our multidisciplinary teams, in all eight designated cancer centres.” According to Professor Ray McDermott, Consultant Medical Oncologist at Tallaght and St Vincent’s University Hospitals, Dublin and Clinical Director with prostate cancer research initiative iPROSPECT: “The increase in survival rates for prostate cancer patients over recent decades is a testament to the work of research scientists in Ireland and across the globe. They have worked tirelessly in their battle against this disease and have saved countless lives. “But survival rates only show one side of the journey a patient with this disease goes through. For survivors, their diagnosis and treatment often impacts their physical and mental wellbeing in ways men rarely speak openly about.


Prescribing Information (Ireland) ▼Vargatef® 100 mg and 150 mg soft capsules Soft capsules containing 100 mg or 150 mg nintedanib (as esilate). Indication: Vargatef is indicated in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy. Dose and Administration: Treatment with Vargatef should be initiated and supervised by a physician experienced in the use of anticancer therapies. The recommended dose of nintedanib is 200 mg twice daily administered approximately 12 hours apart, on days 2 to 21 of a standard 21 day docetaxel treatment cycle. Vargatef must not be taken on the same day of docetaxel chemotherapy administration (= day 1). If a dose of nintedanib is missed, administration should resume at the next scheduled time at the recommended dose. The individual daily doses of nintedanib should not be increased beyond the recommended dose to make up for missed doses. The recommended maximum daily dose of 400 mg should not be exceeded. Patients may continue therapy with nintedanib after discontinuation of docetaxel for as long as clinical benefit is observed or until unacceptable toxicity occurs. For posology, methods of administration, and dose modifications of docetaxel, please refer to the corresponding product information for docetaxel. Dose adjustments should be considered in case of adverse events of pre-specified severity: diarrhoea, vomiting, nausea and other non-haematological or haematological adverse reactions, and aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) and bilirubin elevations – as initial measure for the management of adverse reactions treatment with nintedanib should be temporarily interrupted. Please refer to the Summary of Product Characteristics (SPC) for further information including when to discontinue treatment. Paediatric population: Safety and efficacy in children aged 0-18 years have not been established. Elderly patients (≥ 65 years): No overall differences in safety and efficacy were observed for elderly patients. No adjustment of initial dosing required on the basis of a patient’s age. Race and body weight: Based on population pharmacokinetic analyses, no a priori dose adjustments necessary. Safety data for Black and African American patients are limited. Renal impairment: Less than 1 % of a single dose of nintedanib is excreted via the kidney. Adjustment of the starting dose in patients with mild to moderate renal impairment is not required. The safety, efficacy and pharmacokinetics have not been studied in patients with severe renal impairment (< 30 ml/min creatinine clearance). Hepatic impairment: Nintedanib is predominantly eliminated via biliary/faecal excretion (> 90%). Exposure increased in patients with hepatic impairment (Child Pugh A, Child Pugh B). No adjustment of the starting dose is needed for patients with mild hepatic impairment (Child Pugh A) based on clinical data. Limited safety data available from 9 patients with moderate hepatic impairment (Child Pugh B) are insufficient to characterize this population. The safety, efficacy and pharmacokinetics of nintedanib have not been investigated in patients with severe hepatic impairment (Child Pugh C). Treatment of patients with moderate (Child Pugh B) to severe (Child Pugh C) hepatic impairment is not recommended. The capsules must be taken orally, preferably with food, swallowed whole with water, and must not be chewed or crushed. Contraindications: Hypersensitivity to nintedanib, peanut or soya, or to any of the excipients. Warnings and Precautions: Patients with gastrointestinal disorders including diarrhoea, nausea and vomiting may require interruption, dose reduction or discontinuation of therapy. Diarrhoea should be treated at first signs with adequate hydration and anti-diarrhoeal medicinal products, e.g. loperamide. Supportive care for nausea and vomiting may include medicinal products with anti-emetic properties, e.g. glucocorticoids, anti-histamines or 5-HT3 receptor antagonists and adequate hydration. In the event of dehydration, administration of electrolytes and fluids is required. Plasma levels of electrolytes should be monitored, if relevant gastrointestinal adverse events occur. Combination treatment with docetaxel is associated with a higher frequency of neutropenia of CTCAE grade ≥ 3 as compared to treatment with docetaxel alone. Subsequent complications such as sepsis or febrile neutropenia have been observed. Blood counts should be monitored during therapy, please refer to SPC. Hepatic function: Based on increased exposure, the risk for adverse events may be increased in patients with mild hepatic impairment (Child Pugh A). Treatment with Vargatef is not recommended in patients with moderate or severe hepatic impairment. Nintedanib was associated with an elevation of liver enzymes (ALT, AST, ALKP, gamma-glutamyltransferase) or bilirubin, with a potentially higher risk for female patients. These increases were reversible in the majority of cases. Transaminase, ALKP and bilirubin levels should be investigated before initiation of combination treatment and monitoring continued as required. If relevant liver enzyme elevations are measured, interruption, dose reduction or discontinuation of the therapy with Vargatef may be required, please refer to the SPC. VEGFR inhibition might be associated with an increased risk of bleeding. Vargatef is not recommended in patients with recent pulmonary bleeding (> 2.5 ml of red blood) as well as patients with centrally located tumours with radiographic evidence of local invasion of major blood vessels or radiographic evidence of cavitary or necrotic tumours. Patients taking concomitant anticoagulation, such as warfarin or phenprocoumon should be monitored regularly for changes in prothrombin time, international normalized ratio (INR), and clinical bleeding episodes. Patients with stable brain metastasis should be closely monitored for signs and symptoms of cerebral bleeding. Treatment not recommended for patients with active brain metastasis. Patients should be closely monitored for thromboembolic events and Vargatef should be discontinued in patients with lifethreatening venous thromboembolic reactions. Caution should be used when treating patients with a higher cardiovascular risk including known coronary artery disease. Treatment interruption should be considered in patients who develop signs or symptoms of acute myocardial ischaemia. Based on the mechanism of action patients treated with Vargatef may have an increased risk of gastrointestinal perforations. Particular caution should be exercised when treating patients with previous abdominal surgery or a recent history of a hollow organ perforation. Treatment should only be initiated at least 4 weeks after major surgery. Therapy should be permanently discontinued in patients who develop gastrointestinal perforation. Nintedanib may impair wound healing. Treatment should therefore only be initiated or, in case of perioperative interruption, resumed based on clinical judgement of adequate wound healing. Caution should be exercised in patients who may develop QTc prolongation. Dietary soya-products are known to cause allergic reactions including severe anaphylaxis in persons with soya allergy. Patients with known allergy to peanut protein carry an enhanced risk for severe reactions to soya preparations. Nintedanib exposure increased linearly with patient age, was inversely correlated to weight, and was generally higher in patients of Asian race which may result in a higher risk of developing liver enzyme elevations; close monitoring is recommended in patients with several of these risk factors. Close monitoring is recommended in patients weighing < 50 kg. Interactions: Interaction studies have only been performed in adults. P-glycoprotein (P-gp): Nintedanib is a substrate of P-gp. If co-administered, potent P-gp inhibitors e.g. ketoconazole or erythromycin may increase exposure to nintedanib. Patients should be monitored closely for tolerability of nintedanib. Potent P-gp inducers e.g. rifampicin, carbamazepine, phenytoin and St. John’s Wort may decrease exposure to nintedanib. Co-administration should be carefully considered. Cytochrome (CYP)- enzymes: Likelihood of drug-drug interactions with nintedanib based on CYP metabolism considered to be low. Other medicinal products: The potential for interactions with hormonal contraceptives was not explored. Fertility, Pregnancy and Lactation: Nintedanib may cause foetal harm in humans; women should avoid becoming pregnant while receiving this treatment and use adequate contraception during and for at least 3 months after the last dose of Vargatef. Since the effect of nintedanib on the metabolism and efficacy of contraceptives has not been investigated, barrier methods should be applied as a second form of contraception, to avoid pregnancy. There is no information on the use of Vargatef in pregnant women, but pre-clinical studies have shown reproductive toxicity and therefore nintedanib should not be used during pregnancy unless the clinical condition requires treatment. Pregnancy testing should be conducted at least prior to treatment. Female patients should be advised to notify their doctor or pharmacist if they become pregnant during therapy. If the patient becomes pregnant while receiving Vargatef, she should be apprised of the potential hazard to the foetus. Termination of the treatment with Vargatef should be considered. There is no information on the excretion of nintedanib and its metabolites in human milk. Pre-clinical studies showed that small amounts of nintedanib and its metabolites (≤ 0.5 % of the administered dose) were secreted into milk of lactating rats. A risk to the newborns/infants cannot be excluded. Breast-feeding should be discontinued during treatment with Vargatef. Based on preclinical investigations there is no evidence for impairment of male fertility. There are no human or animal data on potential effects of nintedanib on female fertility available. Undesirable effects: The most frequently reported adverse reactions specific for nintedanib were diarrhoea, increased liver enzymes (ALT and AST) and vomiting. Very common (≥ 1/10): Neutropenia (includes febrile neutropenia), decreased appetite, electrolyte imbalance, peripheral neuropathy, bleeding, diarrhoea, vomiting, nausea, abdominal pain, alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, mucositis (including stomatitis), rash. Common (≥ 1/100 < 1/10): Febrile neutropenia, abscesses, sepsis, dehydration, venous thromboembolism, hypertension, hyperbilirubinaemia, gamma-glutamyltransferase increased. Prescribers should consult the Summary of Product Characteristics for further information on side effects and recommended measures. Pack sizes: 100 mg 120 capsules; 150mg 60 capsules. Legal category: POM. MA numbers: 100 mg: EU/1/14/954/002; 150 mg: EU/1/14/954/004. Marketing Authorisation Holder: Boehringer Ingelheim International GmbH, Binger Strasse 173, 55216 Ingelheim am Rhein, Germany. Prescribers should consult the Summary of Product Characteristics for full prescribing information. Additional information is available on request from Boehringer Ingelheim Ireland Ltd, The Hyde Building, The Park, Carrickmines, Dublin 18. Prepared in October 2016

EXTENDING WHAT’S POSSIBLE VARGATEF®, the only triple angiokinase inhibitor for advanced adenocarcinoma of the lung after first-line chemotherapy1 VARGATEF® is indicated in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer of adenocarcinoma tumour histology after first-line chemotherapy1

This medicinal product is subject to additional monitoring. Adverse events should be reported to the Health Products Regulatory Authority at www.hpra.ie or by email to medsafety@hpra.ie. Adverse events should also be reported to Boehringer Ingelheim Pharmacovigilance on 01 291 3960 or by email to PV_local_uk_ireland@boehringer-ingelheim.com

Reference: 1. VARGATEF® 100/150mg Summary of Product Characteristics. Available at: http://www.medicines.ie/medicine/16211. Accessed October 2016. IRE/VAR-161124a(1) Date of preparation: October 2016


92 Feature Nurse-Led Clinics “Cancer research can address these impacts through studying survivors’ own experiences and finding ways to personalise their treatment and care. That is why investment in cancer research by the Irish Cancer Society and Movember – funded through you, the public – is so essential.” Meanwhile, in other news, the Irish Cancer Society has come out to say that prostate cancer survivors need more support post-treatment. In partnership with The Movember Foundation, the Society has said that while survival rates for prostate cancer were steadily increasing, up from 68.9% to 90.6% over the last 20 years according to most recent figures*, men are still in need of a lot of post-treatment support. The Irish Cancer Society, with support from Movember, funds two specialist nurse-led side effects clinics in Galway University Hospital and St. James’ Hospital Dublin for men who have been diagnosed with prostate cancer. This was a direct response to the results of a survey of prostate cancer survivors carried out in 2011 which found that a significant proportion of men said they were not prepared for and had difficulty coping with, the severity of the physical and emotional side-effects of their treatment. Mary Cremin, Care, Advice, Support and Education (CASE) Nurse in St. James’ Hospital said, “It is really important that the appropriate supports are available for men after a prostate cancer diagnosis. Some of the side-effects, such as incontinence and erectile dysfunction, are very difficult to deal with and can be a cause of a lot of extra stress and worry for patients. This is where cancer support services are so valuable. Things like peer to peer groups are extremely beneficial as men can talk to people who have been through it all before. “Besides the huge challenge of dealing with the physical impacts of a cancer diagnosis, there is also the emotional and psychological effects to think about. It’s assumed that men are typically that bit slower to seek out help from support

Professional Top100 - 2016 • HPN

services but in my experience they are very open about talking about their worries and concerns. Movember and mental health awareness campaigns have definitely helped in that respect. Psychological support is often needed post-surgery when they are feeling worried about incontinence and do not socialise as much as they used to. They must have a decent quality of life and we help them achieve that. Detection and diagnosis Prostate cancer is the most common cancer among Irish men, making up almost a third of all male cancers. The improved detection of prostate cancer means that now around 3,400 new cases of the disease are identified in Ireland each year. Currently the first detection tests men will undergo are the PSA blood test – which measures a protein made by the prostate gland called prostate specific antigen – and a digital rectal examination. The FDA approved the PSA test for prostate cancer screening in 1994. Since then PSA testing has increased 12-fold in Ireland, according to 2012 estimates. The use of widespread PSA testing here has contributed to a high measured incidence of prostate cancer in this country– in 2012 it was the fourth highest across Europe and the tenth highest globally. But the PSA test can only indicate a prostate problem - it doesn’t specifically diagnose prostate cancer. PSA levels in the blood stream can rise if you have prostate cancer but it can rise for other reasons as well. Therefore, it is important that a PSA test is undertaken as part of an overall assessment of the likely presence of prostate cancer under clinician guidance and typically followed up with other more specific diagnostic tests. Forty years ago if a man was suspected of having prostate cancer there was no specific clinical pathway they would follow. Today if the GP suspects a man may have prostate cancer they will refer them to a urology department, often through one of the Rapid Access Prostate

Clinics. These special clinics, set up in the 2000’s, provide a fast, efficient service for men who need further tests done to assess for prostate cancer and are located in the eight designated cancer centres in Ireland. At these clinics a man will typically have a Trans-rectal Ultrasound Scan followed by a Trans-rectal Needle Biopsy of the suspect prostate gland. From these biopsy results a diagnosis can then be made. Newer imaging techniques may also be employed to get more detailed information, if required. All of these techniques make obtaining a detailed diagnosis easier and less invasive than what would have been the case in 1976. Treatment The treatment a prostate cancer patient receives depends on factors including how early the disease is detected, how the cancer cells look under the microscope and the patient’s health. Surgery is still one of the most effective ways to treat prostate cancer that hasn’t spread, and it has become more sophisticated over the past 40 years. Initial surgical techniques removed the whole prostate but often damaged surrounding nerves and blood vessels, leading to impotence and incontinence issues. As a result, prostatectomy was not commonly performed. In 1983 a modified surgical technique was developed that avoided damaging these vital nerves and blood vessels supporting normal working of the penis. This and the ultrasoundguided ‘biopsy’ diagnostic tool led to a huge increase in the number of successfully treated prostate cancer patients who were treated by prostatectomy. Today, the removal of prostate cancer is more commonly done by keyhole surgery, which is far less traumatic for the body than open surgery. The main advantages of this less invasive surgery are that patients lose less blood, have less pain, spend less time in hospital and heal more quickly.

Other treatment options that have been developed and improved on since 1976 include radiotherapy, which can get rid of the cancer completely in more than 6 out of 10 men with early prostate cancer, hormone drug therapy, usually for stage three prostate cancers and for men with high PSA levels, and chemotherapy, for advanced prostate cancers. More personalised treatment In Ireland, one in five men with prostate cancer will go on to develop metastatic prostate cancer – where their cancer has spread to other parts of the body – and succumb to their disease within ten years. In addition, approximately 200 Irish men per year are initially diagnosed with metastatic prostate cancer; of these less than one in five (19%) are expected to be alive after five years. In 1976 there were very little treatment options available for men with metastatic prostate cancer. In recent years, several new treatments for metastatic prostate cancer have become available which have expanded the options for patients and their doctors. The challenge now lies in selecting the most appropriate treatment and determining the order in which they should be given. We now know that not all cancer patients respond in the same way to these treatments. It’s important to find indicators of disease (known as markers), which can predict an individual patient’s response to treatment. To support research in this area, the Irish Cancer Society and the Movember Foundation are supporting a research initiative that is looking at developing personalised treatment options for patients with advanced prostate cancer. Established in 2014, iPROSPECT (Irish Programme for Stratified Prostate Cancer Therapy) is investigating markers in blood or tissue that can predict each patient’s response to treatment and ultimately improve outcomes.


XOFIGO® prolongs the overall survival of patients with castration-resistant prostate cancer (CRPC) by intensive treatment at sites of bone metastases. Introduce Xofigo® for patient progressing on second-generation hormonal therapy1,2

v This medicinal product is subject to additional monitoring. Adverse events and product complaints should be reported. To report an adverse event or a product complaint about a Bayer product, please call Bayer on 01 2999 313. Adverse events and product complaints may also be reported to HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; e-mail: medsafety@hpra.ie. Xofigo 1100 kBq/mL solution for injection (radium Ra 223 dichloride) Please refer to full Summary of Product Characteristics (SmPC) before prescribing. Composition: Active ingredient: radium Ra 223 dichloride (radium-223 dichloride, 1100 kBq/ml, corresponding to 0.58 ng radium-223 at the reference date). Each vial contains 6 mL of solution (6.6 MBq radium-223 dichloride at the reference date). Contains sodium. Indication: Treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases. Dosage and Administration: Xofigo should be administered only by persons authorised to handle radiopharmaceuticals in designated clinical settings and after evaluation of the patient by a qualified physician. Recommended dose is an activity of 55 kBq per kg body weight, given at 4 week intervals for 6 injections. Safety and efficacy beyond 6 injections with Xofigo have not been studied. Xofigo is administered by slow intravenous injection (generally up to 1 minute). The intravenous access line or cannula must be flushed with isotonic sodium chloride 9mg/ml (0.9%) solution for injection before and after injection of Xofigo. No dosage adjustment is considered necessary in elderly patients, patients with hepatic impairment or in patients with renal impairment. Safety and efficacy of Xofigo in children and adolescents below 18 years of age have not been studied. Contraindications: No known contraindications. Warnings and Precautions: Bone marrow suppression, notably thrombocytopenia, neutropenia, leukopenia and pancytopenia, has been reported. Haematological evaluation of patients must be performed at baseline and prior to every dose. In case there is no recovery in values for absolute neutrophil count (ANC) and haemoglobin within 6 weeks after the last administration of Xofigo despite receiving standard of care, further treatment with Xofigo should only be continued after careful benefit/risk evaluation.

Patients with evidence of compromised bone marrow reserve e.g. following prior cytotoxic chemotherapy and/or radiation treatment (EBRT) or patients with advanced diffuse infiltration of the bone (EOD4; “superscan”), should be treated with caution as an increased incidence of haematological adverse reactions such as neutropenia and thrombocytopenia has been observed. Limited available data indicates that patients receiving chemotherapy after Xofigo had a similar haematological profile compared to patients receiving chemotherapy after placebo. Crohn’s disease and ulcerative colitis: due to the faecal excretion of Xofigo, radiation may lead to aggravation of acute inflammatory bowel disease, therefore Xofigo should only be administered to these patients after a careful benefit-risk assessment. In patients with untreated imminent or established spinal cord compression, treatment with standard of care, as clinically indicated, should be completed before starting or resuming treatment with Xofigo. In patients with bone fractures, orthopaedic stabilisation of fractures should be performed before starting or resuming treatment with Xofigo. In patients treated with bisphosphonates and Xofigo, an increased risk of development of osteonecrosis of the jaw (ONJ) cannot be excluded. In the phase III study, cases of ONJ have been reported in 0.67% patients (4/600) in the Xofigo arm compared to 0.33% patients (1/301) in the placebo arm. However, all patients with ONJ were also exposed to prior or concomitant bisphosphonates and prior chemotherapy. Xofigo contributes to a patient’s overall long-term cumulative radiation exposure and therefore may be associated with an increased risk of cancer and hereditary defects. No cases of Xofigo-induced cancer have been reported in clinical trials in followup of up to three years. Depending on the volume administered, Xofigo can contain up to 2.35 mmol (54 mg) sodium per dose. Undesirable effects: Very common: thrombocytopenia, diarrhoea, vomiting, nausea; Common: neutropenia, pancytopenia, leukopenia, injection site reactions; Uncommon: lymphopenia. Classification for supply: Medicinal product subject to restricted medical prescription. Marketing Authorisation Holder: Bayer Pharma AG. 13342 Berlin. Germany. MA number(s): EU/1/13/873/001. Further information available from: Bayer Ltd., The Atrium, Blackthorn Road, Dublin 18. Tel: 01 2999313. Date of Preparation: October 2015

References: 1. Mohler JL, Armstrong AJ, Bahnson RR, et al. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Prostate Cancer. Version 2.2016. National Comprehensive Cancer Network; 2016:1-108. 2. Mottet N, Bellmunt J, Briers E, et al. Guidelines on Prostate Cancer. European Association of Urology; 2015 :1-156. 3. Xofigo® (radium Ra 223 dichloride) solution for injection Summary of Product Characteristics (SmPC), Bayer Pharma AG, 13342 Berlin, Germany, 2016.

© 2016 Bayer Pharma AG. September 2016. L.IE.MKT.09.2016.0632


Section A – General Information All patients with stroke have access to a designated stroke rehabilitation inpatient unit and 94 Feature subsequently a specialist stroke team within the community if required. All medically stable patients with stroke are transferred from the acute stroke unit without delay. There should be no exclusion policy restricting entry to the stroke rehabilitation unit.

Post Stroke Care in Ireland From the 26 (26/29) sites who responded to the survey, 46% (12/26) had bed access which was age restricted (Figure 2). This was restricted to over 65 year olds in 58% (7/12) of these sites.

Three out of four of the country’s rehabilitation hospitals admit they are unable to provide stroke patients with the recommended level of therapy they need, according to a HSE audit. Just one in four has a dedicated stroke unit and 60% lack a stroke specialist to oversee rehabilitation. Less than one in three units has access to psychological services. In addition, the vast majority of the 26 hospitals that took part in the study have no access to community rehabilitation teams to continue therapy that is essential to assist recovery for patients after they are discharged home.

Admission age restriction (n=26) 8%

Figure 2: Bed access age restriction

4% None

7% 54% 27%

Over 65 years old Over 50 years old Over 55 years old

Individual cases basis

Figure 2: Bed access age restriction

The study by the Irish HeartOver all sites there were 559 beds available for all rehabilitation including stroke and Foundation (IHF) and the HSE’s national stroke programmeother is the conditions such as orthopaedic problems although on two sites, which were first to examine post-strokelevel care two type (local selected GP-referred medical patients), for stroke patients in 42% (11/26) is the hospitals rehabilitation theyhospital receive withGeneral Results in Ireland and follows on a national of sites recovering the illavailable effects of to medical admissions also and not only these bedswhile were potentially forwith a further 42% being audit of stroke care published From the 26 (26/29) sites who provided by a medical consultant, their stroke. rehabilitation. earlier this year. This showed a responded to the survey, 46% most commonly a geriatrician. 25% reduction in deaths from the (12/26) had bed access which was The first phase of a new audit of condition in seven years but age restricted (Figure 2). This wasone further The degree of cover varied and stroke services Ireland, Irishunit or ward Inalso 27% (7/26) there was in a dedicated for stroke patients, with pointed to deficits in staffing. restricted to over 65 year olds in was not captured in this survey. Heart Foundation/HSE National site havingStroke dedicated beds but no dedicated Insites. total there were 58%ward/unit. (7/12) of these Out104 of normal working hours Audit 2015, demonstrated Almost two thirds of those dedicated facilities beds identified for stroke rehabilitation patients, with one site providing 29 cover is provided by a medical that acute stroke services have surveyed, 60%, did not have a Over all sites there were 559 Non Consultant Hospital Doctor improved over the last tenanyears. of those beds. Figure 3 provides overview of the distribution of rehabilitation beds. stroke specialist. beds available for all rehabilitation (NCHD) in 46% (12/26) of sites as the clock moves away Some sitesHowever with dedicated stroke units only quoted the dedicated stroke beds inwith some including stroke and other 35% being provided by from the early hours of stroke Professor Joe Harbison is the conditions such as orthopaedicbeds onout instances, management, which underrepresents the number of general rehabilitation some of hours General Practitioner deficiencies in National Clinical Lead for Stroke problems although on two (GP) services. services provided become more and in publishing the reportsites. says sites, which were level two type apparent. The acute audit also that while this second audit shows hospitals (local hospital with There are consultant led ward that almost 20% of encouraging improvement in manythe highlighted selected GP-referred medical rounds From responses there were 191 stroke patients across all sites who wereat least once a week in stroke patients discharged from areas of stroke care, there is still patients), these beds were 92% (24/26) sites, with 35% undergoingacute rehabilitation, patientspotentially (range 1-29). hospitals aremedian admitted7to persistent, substantial, deficits available to medical having rounds twice or more rehabilitation units. in services. admissions also and not only per week. Doctor led outpatient for rehabilitation. services are available on site in The primary objective in the 77% of hospitals had no dedicated 39% (10/26) of sites, the majority stroke unit compared to just a undertaking of this report was In 27% (7/26) there was a being on sites where the acute quarter in the UK while 61% to survey rehabilitation units dedicated unit or ward for stroke services are co-located. However had no access to a Community throughout the Republic of Ireland, 17 patients, with one further site 4 sites used their day hospital Rehabilitation team. having dedicated beds but no which accept and manage the facility for medical follow up. dedicated ward/unit. In total recovery phase of patients who The audit team recommended there were 104 dedicated beds suffered acute stroke, and assess As a measure of neurorehabilitation investment to provide more identified for stroke rehabilitation level of organisation of services specialist service access, beds, more staff and community patients, with one site providing 29 against national and international spasticity services were accessible teams to deal with the problems of those beds. guidelines. Rehabilitation units to 19% (5/26) of sites with at least highlighted in the report. Professor were defined as sites accepting a 2-week waiting time for review Harbison says there is a need for Some sites with dedicated stroke patients from acute hospitals the norm. around 250 extra therapists to units only quoted the dedicated services and providing inpatient tackle the problems. stroke beds in some instances, Patients had access to rehabilitation prior to a patient which under-represents the physiotherapy, occupational being discharged home or to Stroke is a leading cause of number of general rehabilitation therapy, and speech and language another facility, such as the death and disability worldwide. beds on some sites. therapy on each of the 26 sites. National Rehabilitation Hospital. In Ireland, approximately 10,000 people have a stroke related event From the responses there were Access five days a week to This project is the first cycle annually, with 7,000 acute hospital 191 stroke patients across all these therapies was available of a phase of audit of admissions and upwards of 30,000 sites who were undergoing in 96%, 89%, and 54% of sites rehabilitation services for stroke people living in the community rehabilitation, median 7 patients (physiotherapy, occupational patients in Ireland as part of with disabilities as a result of a (range 1-29). therapy, and speech and language the overall plan for the National stroke. Essential to minimising therapy respectively). A stroke specialist provides cover Stroke Programme. poor outcomes for people affected

Professional Top100 - 2016 • HPN


95

Irish Heart Foundation/HSE National Stroke Audit – Rehabilitation Units 2016 80

Figure 3: Numbers of stroke rehabilitation beds

70

60 50 40 30

Total rehab beds

SPT

SPW

SMD

SMM

FINB

SJR

SJH

SJE

SJCH

ITA

LOUGH

COLUM

SCH

PH

OLH

RHD

CAM

RH

MGH

LCH

MPH

LUH

KUH

DCH

0

BGH

10

HOA

20

Stroke specific beds

Figure 3: Numbers of stroke rehabilitation beds

SPT

SMM

SMD

SJR

SJE

ITA

SPW

SJCH

SJH

FIN

COLUM

SCH

LOUGH

CAM

RHD

PH

OLH

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MGH

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BGH

HOA

Making therapy sessions more site to site. 50% of sites use one Teams were asked if any of effective for patients was also set of patient case notes for all their patients received the Sites were asked howof many admissions hadto.received over the highlighted previous including 12 commonly disciplines to they contribute recommended 45 minutes the use of joint sessions or therapy in the requiredof discipline months. Thirteen the sites provided what was felt to be an accurate number, which Patient goal setting is formally quiet therapy rooms for patients daily. 15% (4/26) of sites felt equated to 830 patients across these sites. The remaining thirteen sites either had to documented in the case notes in with attention deficits. Novel none of their patients met this estimatewith numbers of admissions or the number was unknown. 77% of sites, with agreed goals approaches included the ‘Tasty guideline, 23% (6/26) stating between patients/carers in 69% Tales Baking Group’ coordinated that 100% of their patients met the of sites. by OT in Bantry General Hospital required levels. and GRASP (Graded Repetitive Examples of Innovation Teams were also asked about Arm Supplementary Programme) in 80 access to other disciplines St. Camillus in Limerick. Local teams provided numerous required for a rehabilitation service, 70 examples of innovative projects St Columcille’s Hospital noted the summarised in table 2. 60 and services aimed at providing benefits of the introduction of a better all-round care for stroke 31% patient questionnaire on discharge, 50 of sites had access to clinical patients. This was in spite of psychology, with no site having which led to the development of 40 within a working week. the financial backdrop that has access a patient garden and wellness framed the last number of years 50% programme. This was achieved 30 of sites had access to a within the Irish health service. The medical social worker, with just through local fundraising. 20 two thirds of these available following are just a few examples under of activities and programmes St. Finbarr’s in Cork, a HSE awardwithin 10 a working week. All sites developed by local teams. winning unit, also developed a quoted access to dietetics with 0 available within 7 days Although not all sites provided patient garden for the purpose of 81% information, it was clear that all outdoor exercise and gives every of referral. Irish Heart Foundation/HSE Stroke 2016information sites National aim to provide theAudit best – Rehabilitation patient aUnits discharge and most up-to-date care to All sites discussed stroke patients pack on completion of their their patients. at a multi-professional team inpatient rehabilitation. meeting (MPTM), in all casesRehabilitation at beds Number of stroke inpatients 85% of sites responded that opportunities wereforinboth place for HSCPs to attend Education sessions The Royal Hospitalinternal Donnybrook least one per week, with 6 sites patients and carers are ongoing has a service targeting safe and having meetings more than once related or external training courses to stroke management. Figure 4: Rehabilitation bed occupancy by stroke patients in many sites such as the carers’ efficient discharge of patients via per week. information evening session for an ‘Action Van Service’ which aphasia in St. James’s Hospital. The regular attenders varied from utilises a mobile technician

Discipline

Accessible n (%)

Within 5 days n (%)

Clinical psychology

8 (31)

0 (0)

Medical Social work

13 (50)

8 (31)

Dietetics

26 (100)

15 (58)

Rehabilitation/ Therapy assistants

19 (73)

18 (69) 2 (8)

Orthoptics

18 14 (54)

10 (38)

3 (12)

Podiatry

19 (73)

4 (15)

Pharmacy

22 (85)

19 (73)

Orthotics

who can expedite assessment and installation of essential equipment or minor adaptations in the home environment. By highlighting these innovations it is hoped it may stimulate discussion and collaboration nationally to try and ensure that good ideas have an opportunity to reach the most people helping achieve best practice across all services. Future Planning and Discussion The survey has some important limitations to highlight. The rehabilitation units had challenges in obtaining accurate data around number of admissions and discharge destination of patients due to a lack of a system support, such as HIPE (Hospital Inpatient Enquiry). The designation of beds was answered somewhat inconsistently, with some units quoting all units beds and others where a specialist unit existed only quoting the stroke specific beds. The upshot being that the total rehabilitation bed number is an estimate over the 26 sites but the stroke specific bed

Table 2: Access to rehabilitation disciplines

Table 2: Access to rehabilitation disciplines HPN • Professional Top100 - 2016


96 Feature numbers are more accurate. For consistency and comparison staffing levels were reported as per 10rehabilitation beds in keeping with other reports. This can present an over-estimation of staff in smaller units of for example 6-8 beds. From the returned surveys, 559 rehabilitation beds were identified across 26 sites. Only a quarter of sites had a dedicated stroke unit or ward. Nearly half of sites had an age restriction policy for stroke admissions. Stroke specialist cover was available in 42% of sites with at least weekly consultant physician rounds in 92% of cases. Although it could be viewed as extremely challenging to have speciality beds and physician cover in every site, in particular in smaller rehabilitation units, when viewed from a national perspective there is still large deficiencies and inequity in patient access to specialist stroke rehabilitation throughout the country. Ultimately there appears to be low levels of general rehabilitation beds throughout the country. The lack of dedicated stroke units also can lead to barriers in developing speciality services. Access to spasticity clinics was

used as a proxy of how developed specialty services were on each site. Only 19% of sites felt this service was accessible to them, which suggests that speciality services are still very much in their infancy nationally. One such specialist service is the Brain Injury Programme in the NRH. This programme has access to inpatient beds to treat different types of brain injury including stroke. However taking into account that approximately 120 patients are discharged from the NRH annually with a diagnosis of ischaemic or haemorrhagic stroke excluding subarachnoid haemorrhage, the survey results show that a similar number were referred from the 22 rehabilitation sites alone. This suggests that capacity to accept stroke patients is restricted (National Rehabilitation Hospital, Jan 2009). The core members of the HSCP team were available on all sites. However less than a quarter of sites felt that all stroke patients were receiving the recommended levels of therapy per day, 15% stating that none of their patients were receiving the levels recommended. Coupled with the evidence that levels of HSCPs per 10 rehabilitation beds is lower

than the UK, there is support that increased numbers of HSCPs may be required to achieve guidelines for stroke rehabilitation. At the end of their inpatient journey it is clear that people face uncertainty around ongoing rehabilitation access. Only 19% of sites described access to the 3 ESD teams currently available. CRT was available to only 39% of sites. This suggests deficits in both structure and volume of community services. In conclusion, this survey represents an initial step in reviewing compliance with recommended guidelines in stroke rehabilitation in the post-acute phase of stroke care. The report should provide stimulus for addressing deficiencies in rehabilitation services for stroke patients. It provides a baseline from which progress in improving services can be re-evaluated in tandem with the acute stroke services. Improvements will ensure all stroke patients are given an optimum opportunity to recover to independent living with appropriate supports. Professor Harbison said: “The incidence of stroke in Ireland is rising by about 350 extra cases every year, but we still have a severe shortage of stroke unit beds to accommodate patients,

or the specialist nursing, therapy and medical staff we need to care for them,” said the HSE’s National Clinical Lead for Stroke, Professor Joe Harbison. “We have only about half the acute stroke unit beds we need to meet international standards, and this audit shows an even lower proportion of specialist rehabilitation beds." Dr Paul McElwaine, Stroke Research Fellow, National Clinical Programme for Stroke added, “It makes no sense at all that we have significant investment of expertise and resources to save patients’ lives after a stroke, but then fail to follow through with basic therapy services that will help them recover. “Ireland is at the cutting edge of developing lifesaving treatments such as thrombectomy and thrombolysis to treat stroke. "But we waste much of the benefit of these innovations by failing to provide the therapy that doesn’t just promote recovery and a better quality of life for patients, but also reduces overall health service costs by keeping patients out of nursing homes.”

Trinomia launch in Kilkenny

Pictured at the recent launch of Trinomia in Kilkenny are Richard Kennedy, A. Menarini; Xavier Tort-Martorell, Ferrer Internacional, S.A.; Francis Lynch, A. Menarini; Natalia París Sortes, Ferrer Internacional, S.A. and Johnny Murphy, A.Menarini.

Professional Top100 - 2016 • HPN


NEW aspirin • atorvastatin • ramipril

The 1st polypill licensed for secondary prevention of cardiovascular events in Ireland Trinomia 100 mg/20 mg/10 mg, 100 mg/20 mg/5 mg, 100 mg/20 mg/2.5 mg hard capsules (acetylsalicylic acid, atorvastatin (as atorvastatin calcium trihydrate) and ramipril) Abbreviated Prescribing Information Please consult the Summary of Product Characteristics (SmPC) for full prescribing information. Presentation: Hard capsules containing: two 50 mg acetylsalicylic film-coated tablets, two 10 mg atorvastatin film-coated tablets and one 10 mg ramipril film-coated tablet; or two 50 mg acetylsalicylic filmcoated tablet, two 10 mg atorvastatin film-coated tablets and one 5 mg ramipril film-coated tablet; or two 50 mg acetylsalicylic film-coated tablet, two 10 mg atorvastatin film-coated tablets and one 2.5 mg ramipril film-coated tablet. Uses: Secondary prevention of cardiovascular accidents as substitution therapy in adult patients adequately controlled with the monocomponents given concomitantly at equivalent therapeutic doses. Dosage: Oral administration. 1 capsule per day, preferably after a meal. Swallow with liquid. Do not chew or crush. Avoid grapefruit juice. Patients currently controlled with equivalent therapeutic doses of acetylsalicylic acid, atorvastatin and ramipril can be directly switched. Treatment initiation should take place under medical supervision. Cardiovascular prevention, target maintenance dose of Ramipril is 10 mg once daily. Daily dose in renal impairment based on creatinine clearance - ≥ 60 ml/min, maximum daily dose is 10 mg ramipril; 30-60 ml/min, maximum daily dose is 5 mg ramipril. Contraindicated in hemodialysis and/or with severe renal impairment (creatinine clearance <30 ml/min). Administer with caution with hepatic impairment. Perform liver function tests before initiation of treatment and periodically thereafter. Maximum daily dose of is 2.5 mg ramipril and initiate treatment under close medical supervision. Contraindicated in severe or active hepatic impairment. Start treatment in very old and frail patients with caution. Contraindications: Hypersensitivity to any component, to other salicylates, to NSAIDs, to any other ACE inhibitors, tartrazine, soya or peanut. History of previous asthma attacks or other allergic reactions to salicylic acid or other NSAIDs. Active, or history of recurrent peptic ulcer and/or gastric/intestinal haemorrhage, other kinds of bleeding. Haemophilia and other bleeding disorders. Severe kidney and liver impairment. Hemodialysis. Severe heart failure. Concomitant treatment with methotrexate at a dosage of 15 mg or more per week. Concomitant use with aliskiren-containing products with diabetes mellitus or renal impairment. Nasal polyps associated with ashma induced or exacerbated by acetylsalicylic acid. Active liver disease or unexplained persistent elevations of serum transaminases. Pregnancy, lactation and in women of childbearing potential not using appropriate contraceptive measures. Concomitant treatment with tipranavir, ritonavir, ciclosporin. History of angioedema. Extracorporeal treatments leading to contact of blood with negatively charged surfaces. Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney. Hypotensive or haemodynamically unstable states. Children and adolescents below 18 years of age. Warnings and Precautions: Only for use as a substitution therapy in patients adequately controlled with the monocomponents given concomitantly at equivalent therapeutic doses. Special populations requiring particularly careful medical supervision: Hypersensitivity to other analgesics/ antiinflammatory/antipyretic/antirheumatics or other allergens. Other known allergies, bronchial asthma, hay fever, swollen nasal mucous membranes and other chronic respiratory diseases. History of gastric or enteric ulcers, or of gastrointestinal bleeding. Reduced liver and/or renal function. Particular risk of hypotension: strongly activated renin-angiotensin-aldosterone system, transient or persistent heart failure post MI, risk of cardiac or cerebral ischemia, in case of acute hypotension medical supervision including blood pressure monitoring is necessary. Deterioration of cardiovascular circulation. Glucose 6 phosphate dehydrogenase deficiency. Risk of elevated levels of uric acid. Consumption of substantial quantities of alcohol and/or have a history of liver disease. Diagnosed pregnancy, stop treatment immediately, and, if appropriate, start alternative therapy. ACE inhibitors cause higher rate of angioedema in black patients than in non-black patients. The blood pressure lowering effect of ACE inhibitors is somewhat less in black patients than nonblack patients. Monitoring during treatment is required for: Concomitant treatment with NSAIDs, corticosteroids, SSRIs, antiplatelet drugs, anticoagulants. Signs or symptoms suggestive of liver injury. Stop treatment temporarily prior to elective major surgery and when any major medical or surgical condition occurs. Particularly careful monitoring is required in patients with renal impairment, risk of impairment of renal function, particularly with congestive heart failure or after a renal transplant. Risk of development of

hyperkalaemia – regular monitoring of serum potassium recommended. Specific side-effects: Perform liver function tests periodically if hepatic effects occur. May affect the skeletal muscle and cause myalgia, myositis, and myopathy that may progress to rhabdomyolysis, ask patients to promptly report skeletal muscle effects (muscle pains, cramps or weakness) especially if accompanied by malasie or fever and measure CK levels, stop treatment if significantly elevated or if severe muscular symptoms occur. Do not co-administer with systemic fusidic acid or within 7 days of stopping fusidic acid. Where use of systemic fusidic acid considered essential, discontinue statin treatment during fusidic acid treatment. Reports of rhabdomyolysis in patients receiving fusidic acid and statins in combination. Where prolonged systemic fusidic acid needed, consider need for co-administration of Trinomia and fusidic acid on case by case basis with close medical supervision. Discontinue statin treatment if interstitial lung disease occurs. Monitor patients at risk of diabetes mellitus. Discontinue treatment if angioedema occurs and initiate emergency treatment promptly. Concomitant use of ACE-inhibitors and angiotensin II receptor blockers or aliskiren is not recommended and should not be used in patients with diabetic nephropathy. Anaphylactic reactions during desensitization, consider temporary discontinuation of Trinomia during desensitization. Monitor white blood cells for neutropenia/agranulocytosis and more regularly in the initial phase of treatment, impaired renal function, concomitant collagen disease and other mediciens that can change the blood picture. Cough. Contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Interactions: Acetylsalicylic acid: other platelet aggregation inhibitors, other NSAIDs,and antirheumatics, systemic glucocorticoids, diuretics, alcohol, SSRIs, uricosuric agents, anticoagulant and thrombolytic therapy, digoxin, antidiabetic agents including insulin, methotrexate, valproic acid, , antacids, ACE inhibitors, ciclosporin, vancomycin, interferon ∝, lithium, barbiturates, zidovudine, phenytoin, laboratory tests. Atorvastatin: CYP3A4 inhibitors, CYP3A4 inducers, transport protein inhibitors, gemfibrozil/fibric acid derivatives, ezetimibe, colestipol, fusidic acid, colchicine, digoxin, oral contraceptives, warfarin. Ramipril: potassium salts, heparin, potassiumretaining diuretics and other plasma potassium increasing active substances, antihypertensive agents and other substances that may decrease blood pressure, vasopressor sympathomimetics and other substances, allopurinol, immunosuppressants, corticosteroids, procainamide, cytostatics and other substances that may change the blood cell count, lithium salts, antidiabetic agents including insulin. Monitor as appropriate. Pregnancy and Lactation: Contraindicated in pregnancy. Not recommended during lactation. Women of child-bearing potential should use effective contraception during treatment. Side Effects: Ramipril: Common (≥ 1/100, <1/10): dyspepsia, nausea, diarrhoea, vomiting, digestive disturbances, abdominal discomfort, gastrointestinal inflammation, non-productive tickling cough, bronchitis, sinusitis, dyspnoea, headache, dizziness, rash in particular maculo-papular, blood potassium increased, myalgia, muscle spasms, chest pain, fatigue, hypotension, orthostatic blood pressure decreased, syncope. Atorvastatin: Common: dyspepsia, nausea, diarrhoea, constipation, flatulence, pharyngolaryngeal pain, epistaxis, nasopharyngitis, headache, allergic reactions, hyperglycaemia, myalgia, muscle spasms, pain in extremity, joint swelling, back pain, arthralgia, liver function test abnormal, blood creatine kinase increased. ASA: Very Common (≥ 1/10): Gastrointestinal complaints such as heartburn, nausea, vomiting, stomach ache and diarrhea, minor blood loss from the gastrointestinal tract (micro-bleeding). Common: Paroxysmal bronchospasm, serious dyspnoea, rhinitis, nasal congestion. For less frequent side effects see SmPC. Pack Sizes: Blister containing 28 film-coated tablets. Legal Category: POM. Product Authorisation Numbers: PA 1744/002/001-003. Product Authorisation Holder: Ferrer Internacional, S.A., Gran Vía Carlos III, 94, 08028 Barcelona, Spain. Marketed by: A. Menarini Pharmaceuticals Ireland Ltd. Further information is available on request from A. Menarini Pharmaceuticals Ireland Ltd, 2nd Floor, Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co. Dublin A96 T924 or may be found in the SmPC. Date of Preparation: September 2016 Date of item: September 2016. IR-Tri-012-2016


98 News

New report shows men seeking out new HIV prevention despite government resistance In the wake of World Aids Day, on December 1st this year, a new report, PrEP Access in Europe, by the PrEP in Europe Initiative, a coalition of leading HIV organisations, is calling on European governments and health authorities to make PrEP (preexposure prophylaxis) available to populations at imminent risk of HIV as a matter of urgency. PrEP means taking HIV drugs, daily or as needed, before possible exposure to HIV in order to prevent infection. Its high level of effectiveness is undisputed. Following US FDA approval in 2012, many countries around the world – including Australia, Brazil, Canada, Kenya, France, Peru, South Africa and Thailand – are in the process of introducing PrEP for people at high risk of HIV into their HIV prevention programming. Europe is home to the fastest growing epidemic of HIV in the

world and is lagging behind in terms of HIV prevention. In 2016 at least 30,000 people were infected in the European Union and 140,000 in the whole of the European region. That’s 80 infections a day in the EU alone. Two-thirds are among gay men. New HIV diagnoses in Ireland have increased to their highest level on record in 2015. Provisional data published by the HSE Health Protection Surveillance Centre shows that a total of 491 people were newly diagnosed with HIV in 2015 – a 30% increase over 2014 figures. Data also shows a significant increase in HIV diagnoses amongst people who inject drugs with a 67% increase in 2015, many of whom are people who are homeless in Dublin. Many of these new infections could be averted by the introduction of PrEP; yet to date the only European country in which

PrEP is available from the national health system is France. The new report is testimony that PrEP is being actively sought regardless of country approval. It presents for the first time European gay men’s accounts of how they are trying to protect themselves in the absence of action from their governments. The Initiative’s report contains anonymous testimony from men and women in over 30 countries. They use a range of ways to buy or get “DiY PrEP” (Do it Yourself PrEP) outside of official health systems. The report reveals that this ranges from “under the counter” prescriptions from sympathetic doctors to ‘borrowing’ a few pills from HIV-positive friends. Without official PrEP approval and availability in health care and community settings, gay men risk taking Truvada® or even other HIV drugs without knowing their HIV

status, STI status, or possible side effect risk. Many will take PrEP needlessly, or ineffectively. Worse, some will take it when they have just been infected, which risks drug-resistant HIV. With the recent marketing authorisation to Truvada as PrEP by the European Commission, it is now imperative that European member states start introducing PrEP into their HIV prevention programmes, drawing on guidelines already developed by the World Health Organisation, the European AIDS Clinical Society and national HIV associations. In addition, accurate information about PrEP needs to be urgently made available to all people at high risk of HIV to ensure they can get PrEP and take it effectively.

GOLD 2017 report updated following FLAME study The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017 report has been published, containing a number of major updates. The GOLD 2017 report is a tool to help healthcare professionals worldwide implement effective COPD management programmes. Released on World COPD Day 2016 they are the first major revision from the organisation in five years. For the first time, the GOLD report has recommended the first-line

use of dual bronchodilators, such as Ultibro® Breezhaler® (indacaterol/glycopyrronium bromide) 110/50 mcg, in the treatment of the majority of symptomatic COPD patients, regardless of their exacerbation risk. Professor Stephen Lane of Adelaide & Meath incorporating the National Children’s Hospital said that “the changes to the GOLD guidelines demonstrate that dual-bronchodilation is now

centre-stage for the treatment of COPD and is the first-line treatment for symptomatic patients irrespective of whether they are exacerbating or not. These changes which were a direct result of the seminal FLAME study recently published in the NEJM, also represent a shift away from the use of inhaled steroid-containing therapies in the treatment of COPD and are now only recommended to be added in a minority of patients following LABA/LAMA treatment,

specifically, those with a history of two or more exacerbations or one hospitalisation in the previous year. The report also clearly identifies the elevated risk of adverse effects (including pneumonia) when using ICS and references evidence showing no significant harm from withdrawing this medication. It’s clear now that the evidence shows LABA/LAMA combinations being the preferred treatment option in all patients for whom a maintenance therapy is recommended.”

UCC School of Pharmacy Prize-Giving The 10th Annual Pharmacy Prizegiving for the 2016 graduating class took place in the Cavanagh Pharmacy Building, Friday 28 October 2016, just prior to student graduation. The prizes presented included: Abbvie Prize for excellence in Pharmaceutics was presented by Dr Mairead Dunne, Abbvie Cork to Tessa Cagney. For the second time Abbvie have sponsored a student prize for excellence in Pharmaceutics. The School appreciated the support of Dr Professional Top100 - 2016 • HPN

Dunne, Site Director who attended at the School for the presentations.

Professor Thomas Walther to Tessa Cagney.

Prize for excellence in Clinical Pharmacy was presented by Dr Suzanne McCarthy of the School of Pharmacy to Tessa Cagney.

Two nominations for the Dr HH Stewart national prize were forwarded for consideration. This is a national competition based on the results of the Objective Structured Clinical Examination (OSCE). They were

Pharmaceutical Chemistry prize for excellence in Pharmaceutical Chemistry was presented by Prof Stephen Byrne to Kyle Malone. Pharmacology prize for excellence in Pharmacology was sponsored by the Department of Pharmacology and Therapeutics and presented by

 Ms. Tessa Cagney  Ms. Ashleigh Meagher The winner of this prize will be announced in mid-November.


THE FIRST APPROVED

UNBOOSTED INTEGRASE INHIBITOR

Models

ENVISION A PATH FORWARD When selecting an adult HIV-1 patient’s first anti-retroviral therapy BHIVA guidelines recommend ISENTRESS (raltegravir) + TDF/FTC as one of 6 preferred treatment regimens1 Isentress is indicated in combination with other anti-retrovirals for the treatment of HIV-1 in adults, adolescents, children, toddlers and infants from the age of 4 weeks. is required. Co-administration of ISENTRESS with antacids containing divalent metal cations may reduce raltegravir absorption by chelation, resulting in a decrease of raltegravir plasma levels. Taking an aluminium and magnesium antacid within 6 hours of ISENTRESS administration significantly decreased raltegravir plasma levels. Therefore, co-administration of ISENTRESS with aluminium and/or magnesium containing antacids is not recommended. Co-administration of ISENTRESS with a calcium carbonate antacid decreased raltegravir plasma levels; however, this interaction is not considered clinically meaningful. Therefore, when ISENTRESS is co-administered with calcium carbonate containing antacids no dose adjustment is required. Co-administration of ISENTRESS with other agents that increase gastric pH (e.g., omeprazole and famotidine) may increase the rate of raltegravir absorption and result in increased plasma levels of raltegravir. Safety profiles in the subgroup of patients in Phase III trials taking proton pump inhibitors or H2 antagonists were comparable with those who were not taking these antacids. Therefore no dose adjustment is required with use of proton pump inhibitors or H2 antagonists. PREGNANCY AND LACTATION Do not use during pregnancy. An Anti-retroviral Pregnancy Registry has been established which physicians are encouraged to use. Breastfeeding is not recommended. SIDE EFFECTS Refer to Summary of Product Characteristics for complete information on side-effects. The safety profile was based on the pooled safety data from two Phase III clinical studies in treatment-experienced patients and one Phase III clinical study in treatment-naïve adult patients. The most frequently reported adverse reactions during treatment were headache and nausea, occurring at 5% or greater. The most frequently reported serious adverse reaction was immune reconstitution syndrome. In treatment-experienced patients, the two randomised clinical studies used the recommended dose of 400-mg twice daily in combination with OBT in 462 patients. In treatment-naïve patients, the multi-centre, randomised, double-blind, active-controlled clinical study used the recommended dose of 400 mg twice daily in combination with a fixed dose of emtricitabine 200 mg (+) tenofovir 245 mg in 281 patients, in comparison to 282 patients taking efavirenz (EFV) 600 mg (at bedtime) in combination with emtricitabine (+) tenofovir. In this pooled analysis of treatment-experienced patients, the rates of discontinuation of therapy due to adverse reactions were 3.9 % in patients receiving ISENTRESS + OBT and 4.6 % in patients receiving placebo + OBT. The rates of discontinuation of therapy in naïve patients due to adverse reactions were 5 % in patients receiving ISENTRESS + emtricitabine (+) tenofovir and 10% in patients receiving efavirenz + emtricitabine (+) tenofovir. Paediatric population Children and adolescents 2 to 18 years of age. Raltegravir has been studied in 126 antiretroviral treatment-experienced HIV-1 infected children and adolescents 2 to 18 years of age, in combination with other antiretroviral agents in IMPAACT P1066 (see sections 5.1 and 5.2). Of the 126 patients, 96 received the recommended dose of ISENTRESS. In these 96 children and adolescents, frequency, type and severity of drug related adverse reactions through Week 48 were comparable to those observed in adults. One patient experienced drug related clinical adverse reactions of Grade 3 psychomotor hyperactivity, abnormal behaviour and insomnia; one patient experienced a Grade 2 serious drug related allergic rash. One patient experienced drug related laboratory abnormalities, Grade 4 AST and Grade 3 ALT, which were considered serious. Clinical adverse reactions related to ISENTRESS (alone or in combination with other ART) are listed below. Any term that includes at least one serious adverse reaction is identified with a dagger (†). Adverse reactions identified from postmarketing experience are included in italics. Frequencies are defined as common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and not known (cannot be estimated from the available data). Common Decreased appetite, abnormal dreams, insomnia, nightmare, abnormal behaviour, depression, dizziness, headache, psychomotor hyperactivity, vertigo, abdominal distention, abdominal pain, diarrhoea, flatulence, nausea, vomiting, dyspepsia, rash, asthenia, fatigue, pyrexia, alanine aminotransferase increased, atypical lymphocytes, aspartate aminotransferase increased, blood triglycerides increased, lipase increased, blood pancreatic amylase increased. Uncommon genital herpes†, folliculitis, gastroenteritis, herpes simplex, herpes virus infection, herpes zoster, influenza, lymph node abscess, molluscum contagiosum, nasopharyngitis, upper respiratory tract infection, skin papilloma, anaemia†, iron deficiency anaemia, lymph node pain, lymphadenopathy, neutropenia, thrombocytopenia, immune reconstitution syndrome†, drug hypersensitivity, hypersensitivity, cachexia, diabetes mellitus, dyslipidaemia, hypercholesterolaemia, hyperglycaemia, hyperlipidaemia, hyperphagia, polydipsia, body fat disorder, mental disorder†, anxiety, suicide attempt†, confusional state, panic attack, suicidal ideation , suicidal behaviour (particularly in patients with a pre-existing history of psychiatric illness) ,amnesia, carpal tunnel syndrome, cognitive disorder, disturbance in attention,dysgeusia, hypersomnia, hypoaesthesia, memory impairment, migraine, neuropathy peripheral, paraesthesia, somnolence, tremor, poor quality sleep, visual impairment, tinnitus, sinus bradycardia, hot flush, hypertension, ventricular extrasystoles, dysphonia, epistaxis, nasal congestion, gastritis†, anorectal discomfort, constipation, epigastric discomfort, erosive duodenitis, eructation, gastrooesophageal reflux disease, gingivitis glossitis, pancreatitis acute, peptic ulcer, rectal haemorrahage, hepatic steatosis, hepatitis†, hepatitis alcoholic, hepatic failure, acne, alopecia, hyperhidrosis, lipoatrophy, dermatitis acneiforme, erythema, facial wasting, lipodystrophy acquired, lipohypertrophy, prurigo, pruritis, rash macular, rash maculopapular, rash pruritic, xeroderma, skin lesion, Stevens Johnson syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), urticaria, arthralgia, arthritis, neck pain, flank pain, osteopenia, tendonitis, rhabdomyolysis, renal failure†, nephritis, nephrolithiasis, nocturia, renal cyst, renal impairment, tubulointerstitial nephritis, erectile dysfunction, gynaecomastia, menopausal symptoms, chest discomfort, face oedema, submandibular mass, oedema peripheral, fat tissue increased. Cancers were reported in treatment-experienced and treatment-naïve patients who initiated ISENTRESS in conjunction with other antiretroviral agents. The risk of developing cancer in these studies was similar in the groups receiving ISENTRESS and in the groups receiving comparators. Grade 2-4 creatine kinase laboratory abnormalities were observed in subjects treated with ISENTRESS. Patients co-infected with hepatitis B and/or hepatitis C virus: The safety profile of ISENTRESS in patients with hepatitis B and/or hepatitis C virus co-infection was similar to that in patients without hepatitis B and/or hepatitis C virus co-infection, although the rates of AST and ALT abnormalities were somewhat higher in the subgroup with hepatitis B and/or hepatitis C virus co-infection for both treatment groups. PACKAGE QUANTITIES 60 tablets. Legal Category: POM. Marketing Authorisation number: EU/1/07/436/001. EU/1/07/436/003. EU/1/07/436/004. Marketing Authorisation holder: Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK. Date of revision: December 2014. © Merck Sharp & Dohme Ireland (Human Health) Limited, 2014. All rights reserved. Further information is available on request from: MSD, Red Oak North, South County Business Park, Leopardstown, Dublin 18 or from www.medicines.ie. Date of preparation: June 2016.

Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie Adverse events should also be reported to MSD (Tel: 01-299 8700) FTC = emtricitabine; TDF = tenofovir disoproxil fumarate. Reference 1. BHIVA guidelines for the treatment of HIV-1 infected adults with antiretroviral therapy - April 2015.

Red Oak North, South County Business Park, Leopardstown, Dublin D18 X5K7 Ireland

INFC-1188292-0000

ISENTRESS® (raltegravir) ABRIDGED PRODUCT INFORMATION Refer to Summary of Product Characteristics before prescribing. PRESENTATION 400 mg film-coated tablet containing 400 mg of raltegravir (as potassium). 25 mg chewable tablets containing 25 mg of raltegravir (as potassium). 100 mg chewable tablets containing 100 mg of raltegravir (as potassium). INDICATIONS For use in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adults, adolescents, and children weighing at least 11 kg. DOSAGE AND ADMINISTRATION Therapy to be initiated by a physician experienced in the management of HIV infection. Posology For use in combination with other active anti-retroviral therapies (ARTs). Adults: 400 mg (one tablet) twice daily. Elderly: Limited information therefore use with caution. Children and adolescents: If at least 25 kg, the recommended dosage is 400 mg (one tablet) twice daily. Children at least 11 kg: weight based to maximum dose 300 mg chewable tablets, twice daily. Because the formulations are not bioequivalent, the chewable tablets should not be substituted for the 400 mg tablet. The chewable tablets have not been studied in HIV-infected adolescents or adults. Renal impairment: No dosage adjustment required. Hepatic impairment: No dosage adjustment required for mild to moderate hepatic impairment. Safety and efficacy not established in patients with severe underlying liver disorders. Use with caution in patients with severe hepatic impairment. Paediatric population: Safety and efficacy of raltegravir in infants below 4 weeks of age have not yet been established. No data are available. Method of administration Oral use. ISENTRESS can be administered with or without food. The 400mg tablets should not be chewed, crushed or split due to anticipated changes in the pharmacokinetic profile. The 100 mg chewable tablet can be divided into equal 50 mg doses. However, breaking the tablets should be avoided whenever possible. CONTRA-INDICATIONS Hypersensitivity. PRECAUTIONS AND WARNINGS Advise patients that current ART does not cure HIV and has not been proven to prevent the transmission of HIV to others through blood contact. While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded. Precautions to prevent transmission should be taken in accordance with national guidelines. Considerable interand intra-subject variability was observed in the pharmacokinetics of raltegravir. Raltegravir has a relatively low genetic barrier to resistance. Therefore, whenever possible, raltegravir should be administered with two other active ARTs to minimise the potential for virological failure and the development of resistance. In treatment naïve patients, the clinical study data on use of raltegravir are limited to use in combination with two nucleotide reverse transcriptase inhibitors (NRTIs) (emtricitabine and tenofovir disoproxil fumarate). Depression, including suicidal ideation and behaviours, has been reported, particularly in patients with a pre-existing history of depression or psychiatric illness. Caution should be used in patients with a pre-existing history of depression or psychiatric illness. Monitor patients with pre-existing liver dysfunction including chronic hepatitis as they have an increased frequency of liver function abnormalities during combination anti-retroviral therapy. Consider interruption or discontinuation if evidence of worsening liver disease exists. Patients with chronic hepatitis B or C and treated with combination anti-retroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions. Osteonecrosis: Although etiology is multifactorial, cases of osteonecrosis have been reported. Advise patients to seek medical advice if they experience joint effects or difficulty in movement. Immune reactivation syndrome: In HIV-infected patients with severe immune deficiency at the time of institution of combination anti-retroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise. Evaluate any inflammatory symptoms and institute treatment when necessary. Autoimmune disorders (such as Graves’ disease) have also been reported to occur in the setting of immune reactivation: however, the reported time to onset is more variable and these events can occur many months after initiation of treatment. Antacids Co-administration of ISENTRESS with aluminium and magnesium antacids resulted in reduced raltegravir plasma levels. Co-administration of ISENTRESS with aluminium and/or magnesium antacids is not recommended. Myopathy and rhabdomyolysis Myopathy and rhabdomyolysis have been reported. Use with caution in patients who have had myopathy or rhabdomyolysis in the past or have any predisposing issues including other drugs associated with these conditions. Severe skin and hypersensitivity reactions Severe, potentially life-threatening, and fatal skin reactions have been reported in patients taking ISENTRESS, in most cases concomitantly with other drugs associated with these reactions. These include cases of StevensJohnson syndrome and toxic epidermal necrolysis. Hypersensitivity reactions have also been reported and were characterized by rash, constitutional findings, and sometimes, organ dysfunction, including hepatic failure. Discontinue ISENTRESS and other suspect agents immediately if signs or symptoms of severe skin reactions or hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema). Clinical status including liver aminotransferases should be monitored and appropriate therapy initiated. Delay in stopping ISENTRESS treatment or other suspect agents after the onset of severe rash may result in a lifethreatening reaction. Rash occurred more commonly in treatment-experienced patients receiving regimens containing ISENTRESS + darunavir compared to patients receiving ISENTRESS without darunavir or darunavir without ISENTRESS. Lactose ISENTRESS filmcoated tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. INTERACTIONS In vitro studies indicate that Raltegravir is not a substrate of cytochrome P450 (CYP) enzymes, does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A, does not induce CYP3A4 and does not inhibit P-glycoprotein-mediated transport. It is not expected to affect the pharmacokinetics of drugs that are substrates of these enzymes or P-glycoprotein. Raltegravir is eliminated mainly by metabolism via a UGT1A1-mediated glucuronidation pathway. Although in vitro studies indicated that raltegravir is not an inhibitor of the UDP glucuronosyltransferases (UGTs) 1A1 and 2B7, one clinical study has suggested that some inhibition of UGT1A1 may occur in vivo based on effects observed on bilirubin glucuronidation. However, the magnitude of the effect seems unlikely to result in clinically important drug-drug interactions. The following information is based on Geometric Mean values; the effect for an individual patient cannot be predicted precisely. Effect of raltegravir on the pharmacokinetics of other medicinal products: Raltegravir did not have a clinically meaningful effect on the pharmacokinetics of etravirine, maraviroc, tenofovir, hormonal contraceptives, methadone, midazolam, or boceprevir. In some studies, co-administration of ISENTRESS with darunavir resulted in a modest decrease in darunavir plasma concentrations; the mechanism for this effect is unknown. However, the effect of raltegravir on darunavir plasma concentrations does not appear to be clinically meaningful. Effect of other agents on the pharmacokinetics of raltegravir: Raltegravir is metabolised primarily via UGT1A1, therefore use caution when co-administering with strong inducers of UGT1A1 (e.g., rifampicin). Rifampicin reduces plasma levels of raltegravir; the impact on the efficacy of raltegravir is unknown. If co-administration with rifampicin is unavoidable, consider doubling the dose of ISENTRESS in adults. There are no data to guide co-administration of ISENTRESS with rifampicin in patients below 18 years of age. The impact of other strong inducers of drug metabolising enzymes, such as phenytoin and phenobarbital, on UGT1A1 is unknown. Less potent inducers (e.g., efavirenz, nevirapine, etravirine, rifabutin, glucocorticoids, St. John’s wort, pioglitazone) may be used. Coadministration with drugs known to be potent UGT1A1 inhibitors (e.g., atazanavir) may increase plasma levels of raltegravir. Less potent UGT1A1 inhibitors (e.g. indinavir, saquinavir) may also increase plasma levels of raltegravir, but to a lesser extent compared with atazanavir. Tenofovir may increase plasma levels of raltegravir too, but mechanism is unknown. The safety profile in patients who used atazanavir and / or tenofovir in trials was similar to that of patients who did not use these agents. Therefore no dose adjustment


100 News

Fresenius host 5th ASSIG meeting The 5th annual Aseptic Services Special Interest Group (ASSIG) meeting took place in the Conrad Hotel webcast to the River Lee Hotel in Cork on 3rd November. It was hosted by Fresenius Kabi.

Chair Deirdre Smith, St Vincent's University Hospital, Sandra Kilpatrick, Southern Trust, Speaker Louise Byrne, Tallaght Hospital and Nessa Madigan, IV Generics & Standard Solutions Business Manager, Fresenius Kabi

The Aseptic Services Special Interest Group and its members are a specialised body of individuals, responsible for the preparation of medicinal products in Irish hospitals. The role of the HPAI Aseptic Services Special Interest Group (ASSIG) is to create a communication network for pharmacists working in aseptic services, to facilitate and organise study days and to promote the role of the specialist aseptic services pharmacist. One of the main activities of the group is to organise bi-annual educational sessions on topics of interests to members. For the November meeting the group decided to focus on the topic of training staff in the aseptic unit. Deirdre Smith, Aseptic ACU Manager at St Vincent’s Private Hospital chaired the meeting. She told Hospital Professional News, “It is imperative that all staff working within aseptic units are properly trained in all areas of aseptic manufacture. “The correct preparation of our products and our quality assurance system for these products relies upon this. The meeting was held in the Conrad Hotel in Dublin with a webcast to the River Lee Hotel in Cork which was very convenient for our southern members. “Two speakers with an in-depth understanding of the challenges in this area were arranged with the help of Nessa Madigan in Fresenius Kabi. These were Louise Byrne, Aseptic Unit Manager in Tallaght Hospital and Sandra Kilpatrick, Southern Trust QA Pharmacist in Craigavon Area Hospital. “Two relevant and informative presentations were made, showcasing a wealth of experience and knowledge from both HSE and NHS hospitals. The presentations were well received, with members noting the importance of quality training programmes, documentation and an appreciation of the time investment required to train all grades of staff.” National guidelines for Aseptic Compounding in Irish Hospital Practice were developed in 2013. European legislation for aseptic manufacturing is developed with a particular focus on the Professional Top100 - 2016 • HPN

pharmaceutical industry. With certain exceptions, manufacturers of human medicines are required to hold a Manufacturer’s Authorisation. To obtain an authorisation to manufacture medicinal product, compliance with the principles of Good Manufacturing Practice (GMP) must be demonstrated. Aseptic compounding in Irish hospital pharmacy is exempt from holding a Manufacturer’s Authorisation provided certain criteria are met (Medicinal Products (Control of Manufacture) Regulations, 2007. Section 5 – S.I. No. 539 of 2007). However, the ethos of GMP is equally paramount to ensure that all products compounded are of high quality, safe and effective. It is important, therefore, that the underpinning principals of GMP can be translated transparently and safely into the hospital pharmacy aseptic compounding unit. In the absence of nationally agreed guidelines for aseptic compounding in Irish hospital pharmacy the Hospital Pharmacist Association of Ireland (HPAI) submitted a project to develop guidelines to the Medication Safety Forum in 2010. All pharmacy departments with compounding facilities were invited to contribute. Through consultation with the Health Information and Quality Authority (HIQA) and the Irish Medicines Board (IMB), the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to Good

Practices for the Preparation of Medicinal Products in Healthcare Establishments (PE 010/3) was chosen as the most appropriate guidance to apply to aseptic compounding in Irish hospitals. Louise Byrne, Clinical Lecturer in Trinity College took delegates through the new additions and provided information as to ‘where we are now’ in relation to the H/ PICS guidelines. Louise is currently Aseptic Unit Manager in Tallaght Hospital, a position she has held since 2001. During this time the Aseptic Unit (AU) team have trained many Pharmacists and Pharmaceutical Technicians. Their training programme was developed as part of an MSc thesis in 2007 and Louise’s presentation focused on the approach the team has to the technical training of aseptic unit staff. The content of the training section of the different guidelines H-PICs, GMP 2015, ISO 9001 was presented. The 5th edition of the Quality Assurance of Aseptic Preparation Services Standards contained the most specific guidelines. It lists the content of a training manual and should be consulted if updating a training manual. Louise says, “Training in Tallaght Hospital concentrates on developing competency in the steps in the compounding process, QC and other miscellaneous activities. The level of training required depends on the person’s role. It involves observing the process while the trainer completes

the task, reading SOPs and becoming familiar with support documents. “The trainee is then expected to complete the task under supervision and finally completing alone. Trainees are expected to gather tables of evidence for their training folder. They must observe particular products and understanding is assessed by asking questions before sign off. Training is ongoing and a continuous training log is in place. All staff members train new staff but only the Senior Pharmaceutical Technician’s and the AU manager can sign someone off as being competent. “A number of useful external resources and training packages are used to support and develop training in Tallaght Hospital such as the T-SET, University of Leeds, and Pre and In Process Checking, in addition to in-house training. “The importance of documenting the time spent training was highlighted and how this can be used to support increases in staffing or developing training roles. In Tallaght 1/3 of a person’s time is dedicated to training. “It was demonstrated, that despite careful training plans, maintaining experienced staff is difficult given that people move onwards as opportunities arise externally. This can have massive implications for aseptic units where the time to train can be 2 months for pharmacists and up to 3-4 months for technicians.” Louise also emphasised the importance of considering training resources in capacity plans. Deirdre concluded, “With over forty pharmacists in attendance and ten in Cork, this event proved popular with our members and we would like to thank Fresenius Kabi for their support and enthusiasm in facilitating the ASSIG in their educational endeavours.” Nessa Madigan, IV Generics & Standard Solutions Business Manager with Fresenius Kabi said, “This event provided an important platform from which Fresenius Kabi, and our oncology division can be seen as educators and innovators in this sector.”


ONCOLOGY PRODUCT PORTFOLIO 2016 Oncology 755892

Busulfan

60mg/10ml

Conc for Sol for Inf

Glass Vial

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EU/1/14/951/001

726575

Carboplatin

50mg/5ml

Conc for Sol for Inf

Glass Vial

Oncology

PA 1422/8/1

726573

Carboplatin

150mg/15ml

Conc for Sol for Inf

Glass Vial

Oncology

PA 1422/8/1

726574

Carboplatin

450mg/45ml

Conc for Sol for Inf

Glass Vial

Oncology

PA 1422/8/1

726576

Carboplatin

600mg/60ml

Conc for Sol for Inf

Glass Vial

Oncology

PA 1422/8/1

729035

Cytarbine

100mg/1ml

Sol for inj./inf

Glass Vial

Oncology

PA 1422/9/1

729034

Cytarbine

1000mg/10ml

Sol for inj./inf

Glass Vial

Oncology

PA 1422/9/1

728353

Cytarbine

2000mg/20ml

Sol for inj./inf

Glass Vial

Oncology

PA 1422/9/1

746490

Docetaxel

20mg/1ml

Conc for Sol for Inf

Glass Vial

Oncology

EU/12/770/005

746491

Docetaxel

80mg/4ml

Conc for Sol for Inf

Glass Vial

Oncology

EU/12/770/001

746487

Docetaxel

120mg/6ml

Conc for Sol for Inf

Glass Vial

Oncology

EU/12/770/002

746488

Docetaxel

160mg/8ml

Conc for Sol for Inf

Glass Vial

Oncology

EU/12/770/003

746489

Docetaxel

180mg/9ml

Conc for Sol for Inf

Glass Vial

Oncology

EU/12/770/004

752668

Etoposide

100mg/5ml

Conc for Sol for Inf

Glass Vial

Oncology

PA 1422/12/1

761192

Etoposide

200mg/10ml

Conc for Sol for Inf

Glass Vial

Oncology

PA 1422/12/1

761663

Gemcitabine 38mg/ml Ethanol Free

200mg/5.26ml

Conc for Sol for Inf

Glass Vial

Oncology

PA 1422/3/5

761664

Gemcitabine 38mg/ml Ethanol Free

1000mg/26.3ml

Conc for Sol for Inf

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761665

Gemcitabine 38mg/ml Ethanol Free

2000mg/52.6ml

Conc for Sol for Inf

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PA 1422/3/5

755325

Irinotecan

40mg/2ml

Conc for Sol for Inf

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PA 1422/16/1

755326

Irinotecan

100mg/5ml

Conc for Sol for Inf

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Irinotecan

300mg/15ml

Conc for Sol for Inf

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731002

Oxaliplatin

50mg/10ml

Conc for Sol for Inf

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Oxaliplatin

100mg/20ml

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Oxaliplatin

200mg/40ml

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Paclitaxel

30mg/5ml

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PA 566/49/1

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Zoledronic Acid

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Plastic Vial

Fresenius Kabi Ltd Unit 3B Fingal Bay Balbriggan, Co. Dublin, Ireland T: +353 (0)1 841 3030 F: +353 (0)1 849 6949 www.fresenius-kabi.ie

SPCs available on request or on the HPRA website Contacts: Sales Representative Gavin Butler - 086 130 0936 Business Manager Nessa Madigan - 086 850 2037

Treatment of bone Diseases

PA 566/61/1


102 News

Schizophrenia secrets found hidden in the folds of DNA Schizophrenia is a disabling condition characterised by delusions, hallucinations, and other significant cognitive difficulties. Affecting almost 1% of the population, more than 50 million people are estimated to have schizophrenia worldwide. It accounts for roughly one-in-five psychiatric admissions in Ireland (second only to depressive disorders) and is the most common reason for involuntary admission. It can be profoundly debilitating for the individual and costly for society. According to Behan and co. (2008), the total direct and indirect cost of schizophrenia to the Exchequer in 2006 was more than ¤460 million. Studying and understanding the condition has proven troublesome; although some of the symptoms can be managed, there is no cure, and how the disease works on a cellular level is not understood. Although schizophrenia holds many secrets, one aspect is well-known - there is a strong genetic component.

It often runs in families, and, for individuals with a first-degree relative with schizophrenia, the risk rises from 1 to 10%. In 2014, a large-scale genome-wide association study of people with schizophrenia linked the disorder to small DNA changes in more than 100 locations in the genome. Surprisingly, the majority of the altered portions were found to lie outside of the actual genes. This perplexed researchers; understanding what roles these snippets of code play in schizophrenia has been challenging. Some of the non-gene locations identified in the studies were found to be in so-called regulatory regions. These sections of code repress or enhance the activity of certain genes that lie close to them within the genome. However, many of these regulatory regions had no obvious gene targets near their location. Each cell has approximately 2 meters of DNA condensed into a nucleus just 6 micrometers across. This feat is the equivalent

of packing 40 kilometres of thin thread into a tennis ball. When DNA is precisely packaged into a chromosome in this way, it is thoroughly twisted and looped. Researchers wondered whether, during these contortions, the schizophrenia-linked sections might come into close contact with distant genes. Researchers from David Geffen School of Medicine at University of California-Los Angeles set out to understand if this was the case. Principal investigator Dr Daniel Geschwind and his team used a state of the art, high-resolution version of a technology known as chromosome conformation capture. Chromosome conformation capture chemically marks and then maps the points at which DNA comes in contact with itself as it folds. Each cell in the human body has subtly different ways of manipulating and packaging its DNA. So, the team decided to focus their search on immature human brain cells in the cortex.

development is thought to be involved in schizophrenia. The researchers found that the majority of the 100 disease-linked sites that had been previously found did indeed contact genes involved in brain development. Additionally, many of these new locations were already known to be involved in schizophrenia or had previously been shown to have increased levels of activity in schizophrenic brains. Some of these newly pinpointed schizophrenia-related genes are activated by acetylcholine, a neurotransmitter thought to be at least partially involved in the development of schizophrenia. In addition to the acetylcholinergic neurons, other genes that are known to be involved in the early development of the cerebral cortex were also implicated by the new technique. Overall, the study, published recently in Nature, identified hundreds of genes that might be abnormally regulated in a schizophrenic brain.

They chose the cortex specifically because its abnormal cortical

New Consultant Surgeon for UL Hospitals UL Hospitals Group has announced the appointment of Mr Colin Peirce, MD, FRCSI, as Consultant Colorectal/General Surgeon. Mr Peirce graduated with first class honours in surgery from Trinity College Medical School, Dublin, in 2004 and previously worked in the UL Hospitals Group as a specialist registrar in general and colorectal surgery in 2012/13. He completed a year of international fellowship in the world-renowned Cleveland Clinic, Ohio, in July 2016, with a strong focus on robotic colorectal surgery. Mr Peirce said he was “very excited and honoured to join the robotic surgery team here in Limerick in what is both a unique opportunity and program within the Irish health service”. He has received a number of national and international awards and accolades and is a keen contributor to the surgical literature. Commenting on the appointment, Colette Cowan, CEO, UL Hospitals

Professional Top100 - 2016 • HPN

Mr Colin Peirce, Consultant Colorectal/General Surgeon

Group said, “We are delighted to have been able to entice Mr Peirce home to join what we feel is one of the best, if not the best Department of Colorectal Surgery in the country. Colin joins Mr David Waldron, Prof Calvin Coffey and Mr Eoghan Condon in what is a great combination of experience and dynamism -one that is proving of great benefit for our reputation as a teaching hospital, and more importantly for all the patients of the MidWest. We have great plans for robotic surgery here at UL Hospitals and Colin is a fantastic addition to the team.”


Introducing the only four-per-year treatment for schizophrenia, giving patients time for what matters Unique

Sustaining

Predictable

Convenient

– freedom from frequent administrations1,2

– effective at preventing relapse1-3

– no new or unexpected adverse events compared to other paliperidone formulations2-4

– simple transition from monthly paliperidone palmitate1

PRESCRIBING INFORMATION Trevicta® 175 mg, 263 mg, 350 mg & 525 mg prolonged release suspension for injection. ACTIVE INGREDIENT(S): 175 mg, 263 mg, 350 mg & 525 mg paliperidone. Please refer to Summary of Product Characteristics (SmPC) before prescribing. INDICATION(S): TREVICTA, a 3-monthly injection, is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1monthly paliperidone palmitate injectable product. DOSAGE & ADMINISTRATION: Intramuscular injection. Patients who are treated with 1-monthly paliperidone palmitate injectable (4 months or more) and do not require dose adjustment may be switched to TREVICTA. Adults: Administer dose in either deltoid or gluteal muscle. Deltoid administration, use 1½ inch, 22 gauge needle (0.72 mm x 38.1 mm) patients 90 kg, or 1-inch, 22 gauge needle (0.72 mm x 25.4 mm) patients < 90 kg. For gluteal administration use the 1½-inch, 22 gauge needle (0.72 mm x 38.1 mm). Initiate TREVICTA in place of the next scheduled dose of 1-month paliperidone palmitate injectable (± 7 days). Base TREVICTA dose on the previous 1-month paliperidone palmitate injectable dose using a 3.5fold higher dose. Thereafter TREVICTA should be administered by intramuscular injection once every 3 months (± 2 weeks). Dose adjustment of TREVICTA can be made every 3 months in increments within the range of 175 mg to 525 mg. Alternate injections between left and right sides. Children: No safety or efficacy data available. Elderly: No safety or efficacy data available for patients > 65 years. Renal impairment: Mild (creatinine clearance ≥ 50 to < 80 ml/min): dose should be adjusted. Stabilise patient using 1-month paliperidone palmitate injectable, and then transition to TREVICTA. Moderate or severe (creatinine clearance < 50 ml/min): Not recommended. Hepatic impairment: Caution in severe hepatic impairment. CONTRAINDICATIONS: Hypersensitivity to paliperidone, risperidone or any of the excipients. SPECIAL WARNINGS & PRECAUTIONS: Do not use in acutely agitated or severely psychotic patients. Not recommended in elderly dementia patients. Caution in cardiovascular disease (including family history of QT prolongation), cerebrovascular disease, hypotension, prolactin-dependent tumours, seizures, Parkinson’s disease and in conjunction with medicines that prolong QT interval. May induce orthostatic hypotension. If tardive dyskinesia occurs consider discontinuing all antipsychotics. Events of leucopenia, neutropenia, and agranulocytosis reported with antipsychotics, including TREVICTA, additional monitoring or cessation of treatment may be required. If Neuroleptic Malignant Syndrome (NMS) occurs discontinue all antipsychotics. Rarely, anaphylactic reactions reported in patients previously tolerating oral risperidone/paliperidone. If occur, discontinue TREVICTA, initiate general supportive measures, monitor until resolved. Appropriate clinical monitoring in diabetics and those with risk factors for diabetes advisable. Advise of potential for weight gain, monitor weight regularly. Priapism reported with oral paliperidone. Caution in patients experiencing conditions which may contribute to core body temperature elevation. Identify all possible risk factors for venous thromboembolism (VTE) before and during treatment and take preventive measures. Antiemetic effect (observed in paliperidone preclinical studies) may mask overdosage with certain medicines, intestinal obstruction, Reye’s syndrome, brain tumour etc. Avoid inadvertent injection into a blood vessel. Intraoperative floppy iris syndrome (IFIS) observed during cataract surgery in patients treated with medicines with alpha1a-adrenergic antagonist effect, such as TREVICTA. SIDE EFFECTS: Very common: insomnia. Common: upper respiratory tract infection, urinary tract infection, influenza, hyperglycaemia, weight increased, weight decreased, agitation, depression, anxiety, parkinsonism, akathisia, sedation/ somnolence, dystonia, dizziness, dyskinesia, tremor, headache, bradycardia, tachycardia, hypertension, cough, nasal congestion, abdominal pain, vomiting, nausea, constipation, diarrhoea, dyspepsia, toothache, transaminases increased, rash, musculoskeletal pain, back pain, arthralgia, amenorrhoea, pyrexia, asthenia, fatigue, injection site reaction. Other side effects reported with paliperidone include: pneumonia, respiratory tract infection, cellulitis, thrombocytopenia, diabetes mellitus, electrocardiogram QT prolonged, subcutaneous abscess, neutropenia, inappropriate antidiuretic hormone secretion, diabetic ketoacidosis, NMS, cerebral ischaemia, unresponsive to stimuli, loss of consciousness, depressed level of consciousness, glaucoma, atrial fibrillation, pulmonary congestion, pancreatitis, faecaloma, urinary retention, hypothermia, agranulocytosis, anaphylactic reaction, water intoxication, diabetic coma, pulmonary embolism, pneumonia aspiration, intestinal obstruction, ileus, angioedema, rhabdomyolysis, injection site necrosis. Other side effects reported with risperidone (paliperidone is the active metabolite of risperidone): Weight gain: 10% of TREVICTA-treated subjects experienced weight gain of ≥ 7%. Laboratory tests: Serum prolactin: increases in serum prolactin observed. Class effects: QT prolongation, ventricular arrhythmias, sudden unexplained death, cardiac arrest, and Torsade de pointes may occur with antipsychotics. Cases of venous thromboembolism, including pulmonary embolism and deep vein thrombosis, also reported. Refer to SmPC for other side effects. REFERENCES: 1. TREVICTA® EU Summary of Product Characteristics. 2. Savitz A et al. Int J Neuropsychopharmacol 2016; doi: 10.1093/ijnp/pyw018. [Epub ahead of print]. 3. Berwaerts J et al. JAMA Psychiatry. 2015;72(8):830–839. 4. Kim E et al. Poster presented at the 15th International Congress of Schizophrenia Research; 28th March - 1st April 2015; Colorado Springs, Colorado, USA.

PREGNANCY: Should not be used during pregnancy unless clearly necessary. LACTATION: Should not be used while breastfeeding. INTERACTIONS: Caution with medicines that prolong QT interval e.g., class IA and class III antiarrhythmics, some antihistaminics, some antibiotics, some other antipsychotics, some antimalarials. Potential for TREVICTA to affect other medicines: Caution in conjunction with: other centrally acting medicines e.g., anxiolytics, antipsychotics, hypnotics, opiates, alcohol; medicines known to lower seizure threshold i.e., phenothiazines, butyrophenones, tricyclics, SSRI’s, tramadol, mefloquine; medicines capable of inducing orthostatic hypotension (an additive effect may be observed when TREVICTA is co-administered); levodopa and other dopamine agonists (paliperidone may antagonize their effect- use lowest effective dose of each treatment if this combination necessary e.g., end-stage Parkinson’s disease). Interaction of TREVICTA with lithium unlikely. Potential for other medicines to affect TREVICTA: Administration of oral paliperidone and paroxetine (a potent CYP2D6 inhibitor) showed no clinically significant effect on paliperidone pharmacokinetics. Co-administration of oral paliperidone once daily with carbamazepine 200 mg twice daily decreases plasma concentration of paliperidone by 37%. Re-evaluate/increase TREVICTA dose at carbamazepine initiation. No clinically significant interaction expected between valproate and TREVICTA. Caution when TREVICTA is co administered with risperidone or with oral paliperidone for extended periods of time. Limited safety data for concomitant use of TREVICTA with other antipsychotics. Refer to SmPC for full details of interactions. LEGAL CATEGORY: Prescription Only Medicine. PRESENTATIONS, PACK SIZES, MARKETING AUTHORISATION NUMBERS:

PRESENTATION 175 mg pre-filled syringe 263 mg pre-filled syringe 350 mg pre-filled syringe 525 mg pre-filled syringe

PACK SIZE

1 dose

MARKETING AUTHORISATION NUMBER EU/1/14/971/007 EU/1/14/971/008 EU/1/14/971/009 EU/1/14/971/010

MARKETING AUTHORISATION HOLDER: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium. FURTHER INFORMATION IS AVAILABLE FROM: Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG UK. Prescribing information last revised: 06/2016 Adverse events should be reported. Healthcare professionals are asked to report any suspected adverse events via: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie, E-mail: medsafety@hpra.ie Adverse events should also be reported to Janssen-Cilag Limited on +44 1494 567447 or at dsafety@its.jnj.com. © Janssen-Cilag Limited 2016

PHIR/PSY/0716/0006 Date of preparation: July 2016


104 News

Frontiers in Healthcare The 3rd Annual Frontiers in Healthcare Conference took place last month (November) at NUI Galway, organised in conjunction with Novartis Ireland. This year’s programme brought together an exciting group of academics, industry professionals and clinicians who debated and discussed a significant issue in healthcare. The theme of this year’s conference was ‘Real World Evidence: its use and potential in improving healthcare decisionmaking’. Among the issues that the speakers addressed were:  How should Real World Evidence be used in reimbursement decisions?  How has Real World Evidence influenced public health guidelines in areas such as alcohol policy, obesity policy, salt intake etc.?  How health outcomes in specific illnesses such as prostate cancer can be measured and why such outcomes are critical in designing more efficient healthcare systems.

“It is about how we get the best value from the budget that we have and from the patient point of view it is about how we remove non-value added from the patient journey.” Mr Kennelly added, “Real world evidence means different things in different contexts and that’s the way it should be. “In normal economics, outside of health economics, one of the things we often say is that the company or business is a black box and in health economics it seems to me that the hospitals are black boxes to health economists.” Professor Frank Sullivan, Director of the Prostate Cancer Institute at NUI Galway looked at real world evidence and prostate cancer outcomes for value. For the last 5 years I have become quite passionate about outcomes and trying to measure the outcomes that are important to patients,” he said. “It is key that we get our processes correct in our healthcare system to get the most out of the resources that we have.

 How can data analytics change how Real World Evidence is collected and analysed in an ethical way in order to improve individual and population health?

But we also have to measure what patients are interested in - which is their medical outcome. How do we do that? We are all charged with the keys words of the moment, ‘patient centred care’ and that is appropriate at the moment. Over the last few decades we have appear to have put the patient to the side, getting more concerned with running our business and our systems and not enough with what the patients are thinking.

One of the new features of this year’s conference was a poster session which included research that has been done by graduates of the M. Sc. (Health Economics) programme at NUI Galway.

“Two to three years ago, money was to follow the patient. I would ask on what basis? To a facility struggling to keep up with access or to the facilities that are providing the best care?”

Chair Brendan Kennelly welcomes the guests stating, “It is a pleasure to see some old faces and great to see so many new faces at this event.

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 What statistical and economic techniques should be employed to ensure that the maximum impact is made from using Real World Evidence to guide decision-making in healthcare?

“This conference is a joint venture between the Health Economics and Policy Analysis Centre at NUI Galway and Novartis and we are grateful for their co-operation and continued support.” CEO of the Ireland East Hospital Group, Professor Mary Day looked at the issue of Lean management in transformation. Reflecting on the process she said, “Lean for me is about how we transform healthcare to reflect value.

Professional Top100 - 2016 • HPN

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1. Gilles Ducorroy, Head of Patient Access, Novartis Ireland, Declan Lee and Stephanie Whyte, HEMAR Associated, Janssen and Brendan Kennelly, Lecturer, Department of Economics, NUI Galway 2. Mr Mark Gouldson, NUIN Galway, with conference guest and Professor Frank Sullivan, Director, Prostate Cancer Institute, NUI Galway 3. David Green, Key Account Manager with Novartis, Declan Noone, NUI Galway and Benedikt Simon, Median Healthcare Group, German 4. Sinead Lucey, Medicines Management Board, Brendan Kennelly, NUI Galway and Phoebe Balkin, Economic Modelling Specialist, Novartis

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Event Gallery 105

Dr Paul Brennan awarded 2016 Burkitt Medal for contribution to cancer research Dr Paul Brennan, Head of the Genetics Section of the International Agency for Research on Cancer (IARC), Lyon, has been awarded the 2016 Burkitt Medal for his contribution to cancer research. The award recognises people with the integrity, compassion and dedication matching that of Denis Burkitt, a Trinity graduate who is known for his discovery of Burkitt lymphoma. Dr Brennan received the medal during the 10th International Cancer Conference, which was recently held in Trinity College Dublin under the theme New Frontiers in Personalised Cancer Care. Dr Paul Brennan received the Burkitt Medal after delivering the Burkitt Lecture: “Cancer Prevention: from Denis Burkitt to the Human Genome Project,” at the Cancer Conference.

Dr Claire Healy, Senior Lecturer Consultant, TCD, Dr Paul Brennan and Professor Paul Browne, Head, School of Medicine, TCD

Dr Emily Porter identified as a ‘Rising Star’ Dr Emily Porter, NUI Galway

An award-winning NUI Galway researcher, Dr Emily Porter, was selected to attend the recent 2016 Rising Stars Workshop for her work on understanding human soft tissue. The workshop was hosted by Carnegie Mellon University in Pittsburgh. The annual academic career event brings together over 60 of the brightest female Ph.D. students, postdocs, and engineers/

scientists in the fields of electrical and computer engineering and computer science. Over the twoday workshop the select group presented their work, and focused on scientific interactions and career-oriented discussions. Dr Porter's research focuses on the dielectric properties of human tissues and their use in the design and development of cutting-edge medical devices. Explaining her research in simple terms, Dr Porter said: “The human body is amazingly complex, and there is still so much to be understood. My interest is in the

electrical properties of our tissues, including how our body interacts with electromagnetic energy such as with mobile phones or magnetic resonance imaging. This work promises to provide insight for building new electromagnetic medical devices for the detection, diagnosis, and treatment of cancers and other diseases.” Based in NUI Galway’s Lambe Institute for Translational Research, Dr Porter works under the supervision of Dr Martin O’Halloran in the Translational Medical Device Lab.

EU Commissioner honoured by UCC The European Commissioner for Research, Science & Innovation, Carlos Moedas was conferred with an Honorary Doctorate at UCC last month in recognition of his contribution to innovation in Europe. “Today we acknowledge the significant contribution of Commissioner Moedas in promoting the international excellence of the EU’s research and innovation capabilities”, said Dr Michael Murphy, UCC President. "We recognise his support for Ireland’s innovation agenda, and admire his Europeanwide vision and commitment. I am pleased on behalf of the University that he is being honoured with an honorary degree of Doctor of Laws,” he said.

As well as a number of high profile dignitaries, research and innovation leaders and university representatives, the Vice President of the European Parliament Mairéad McGuinness MEP was also at UCC to extend her congratulations to Commissioner Moedas. While at UCC, Commissioner Moedas officially opened the University’s flagship innovation building, Western Gateway. Following a day of meetings with University researchers, Commissioner Carlos Moedas was conferred with the honorary doctorate. EU Commissioner Carlos Moedas officially opens the Western Gateway building and is conferred

UCC President, Dr Michael Murphy, EU Commissioner Carlos Moedas and Professor Anita Maguire, Vice President for Research and Innovation at UCC with an Honorary Doctorate. Photo shows L-R UCC President, Dr Michael Murphy, EU Commissioner

Carlos Moedas and Professor Anita Maguire, Vice President for Research and Innovation at UCC. HPN • Professional Top100 - 2016


106 News

On target for 50% increase in transplants Ireland’s National Centre for Kidney Transplantation at Beaumont Hospital has released its 2015 Annual Report showing that kidney transplants performed at the National Kidney Transplant Service (NKTS) are functioning 3 years longer than their European counterparts. As part of the Collaborative European Transplant Study, based at The University of Heidelberg, data was collected from over 400 transplant centres across Europe over a 30 year period. In the European transplant centres surveyed, 50% of all the kidneys transplanted are still functioning after 11 years. However, in patients transplanted at Beaumont Hospital, 50% of kidneys transplanted are still functioning after 14 years. In other positive news, Beaumont Hospital is on course to reach a 50% increase in living donor transplant activity this year, with 46 living donor transplants performed since the start of 2016, up from 33 in total last year. It’s projected that a total of 50 living donor transplants will be completed by year end. To date this year, a total of 103 deceased donor kidney transplants have been performed at the National Kidney Transplant

Aileen Counihan, Transplant Coordinator, Beaumont Hospital; Minister for Health, Simon Harris TD; Dr Conall O’Seaghdha, Consultant Nephrologist and Transplant Physician at Beaumont Hospital; Ms Dilly Little, Transplant Surgeon and Co Clinical Director of Transplant, Urology and Nephrology at Beaumont Hospital

Service, identical to deceased donor kidney transplant numbers in the same period last year. Dr Conall O’Seaghdha, Consultant Nephrologist and Transplant Physician, and Co-Clinical Director of the Transplant, Urology and Nephrology Directorate commented, “Globally, we’re seeing a decline in the number of deceased donor kidneys, primarily due to improvements in road safety and neurosurgical care, but in Ireland the increase in living

donor transplants this year has helped balance this reduction. This is why it's so important that we continue to support and develop living donor kidney transplantation in Ireland. Furthermore, it’s vital that people take time to consider carrying an organ donor card and ensure their families know their wishes should the question ever arise.”

service in Beaumont Hospital has continued to grow and provide innovative, state of the art techniques that allow kidney transplants to be offered to even the most complex cases. A total of 2,343 people currently enjoy the benefits of a functioning kidney transplant in Ireland and I would like to thank the team for their hard work and dedication.”

Ian Carter, CEO, Beaumont Hospital concluded: “For over 50 years, the kidney transplant

Celebrating 10 Years of the Hermitage Medical Clinic Pictured are some of those who attended the recent 2016 Hermitage Clinic Annual Ball, held in the K Club Dublin, celebrating ten years of the Hermitage Medical Clinic. More photos to follow in the January 2017 issue of Hospital Professional News. Picture Captions: 1: Dr Tora Leong, Consultant Cardiologist and Dr Trevor Duffy, Consultant Rheumatologist

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2: Eamonn Fitzgerald, CEO, Mary Shore, COO, Dr John Clarke and Dr Muhammed Jamil, 3: Mr Weng Lee, Consultant Eye Surgeon and Professor Ellen O’Sullivan, Consultant Aneasthetist 4: Anne Donnelly, Lab Manager, Mr David Borton, Consultant Orthopaedic Surgeon and Mary Borton, Consultant Psychologist

Professional Top100 - 2016 • HPN


Clinical R&D 107 GRANTS MARKETING AUTHORISATION FOR MSD’S ZEPATIER™ FOR THE TREATMENT OF CHRONIC HEPATITIS C INFECTION MSD has announced that the European Commission has approved ZEPATIER™ (elbasvir and grazoprevir) with or without ribavirin (RBV) for the treatment of chronic hepatitis C virus (HCV) genotype (GT) 1 or GT4 infection in adults. ZEPATIER is MSD’s once-daily, fixed-dose combination tablet containing the NS5A inhibitor elbasvir (50mg) and the NS3/4A protease inhibitor grazoprevir (100mg). The recent approval allows marketing of ZEPATIER tablets in the 28 countries that are members of the European Union, as well as European Economic Area members, Iceland, Liechtenstein and Norway. Thousands of chronic HCV patients worldwide participated in the ZEPATIER clinical development programme, which was designed to include patients with known treatment challenges, such as those with compensated cirrhosis and those who have previously failed treatment with peginterferon plus RBV, with or without an HCV protease inhibitor. In the trials, sustained virologic response (SVR) 12 weeks after the completion of therapy (SVR12, considered virologic cure based on undetectable HCV RNA levels) was achieved in 96 percent (301/312) of chronic HCV GT1b-infected patients treated with ZEPATIER for 12 weeks. In chronic HCV GT1a-infected patients, 93 percent (483/519) and 95 percent (55/58) achieved cure following treatment with ZEPATIER for 12 weeks or ZEPATIER plus RBV for 16 weeks, respectively. “The approval of ZEPATIER in the EU, following approvals in the United States and Canada earlier this year, is an important step in offering a new and effective treatment for this devastating disease,” said Dr Colm Galligan, Medical Director, MSD in Ireland. “MSD has a legacy of more than 30 years in working to combat chronic hepatitis C infection. We are committed to addressing this silent killer disease and providing treatment options for the greatest number of patients, in an effort to reduce the disease burden worldwide.” Elbasvir/grazoprevir is an investigational, once-daily, fixed-dose combination therapy containing elbasvir and grazoprevir. The combination was granted breakthrough therapy designation by the FDA, for the treatment of patients with chronic HCV GT1 infection with end stage renal disease on haemodialysis,

and breakthrough therapy designation for elbasvir/grazoprevir for the treatment of patients with chronic HCV GT4 infection.

SANOFI RECEIVES CHMP RECOMMENDATION FOR APPROVAL OF SULIQUATM IN THE EU Sanofi has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorization of SuliquaTM, the once-daily titratable fixed-ratio combination of basal insulin glargine 100 Units/ mL and GLP-1 receptor agonist lixisenatide. CHMP recommended the use of Suliqua in combination with metformin for the treatment of adults with type 2 diabetes mellitus to improve glycemic control when this has not been provided by metformin alone or metformin combined with another oral glucose lowering medicinal product or with basal insulin. The CHMP positive opinion is based on data from two Phase 3 studies, LixiLan-O and LixiLan-L, which enrolled more than 1,900 adults with type 2 diabetes worldwide to evaluate the efficacy and safety of the fixed-ratio combination when used in patient populations insufficiently controlled after OADs and after basal insulin therapy, respectively. Both studies met their primary endpoints, demonstrating statistically superior HbA1c reduction versus lixisenatide and insulin glargine 100 Units/mL in LixiLan-O,1 and versus insulin glargine 100 Units/ mL in LixiLan-L.2 Suliqua is the brand name in Europe for the once-daily titratable fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide. The European Commission is expected to make a final decision on marketing authorization for Suliqua in the coming months. The fixedratio combination is currently under review in a total of nine markets, including the United States, where a U.S. Food and Drug Administration decision is anticipated later this month. Once approved, Suliqua will be available in the EU in two prefilled SoloSTAR® pens, providing different dosing options that will help answer individual market and patient needs. The differentiation between the pen strengths is based on the dose range of each pen. The 10-40 SoloSTAR pre-filled pen will deliver 10 to 40 dose steps of insulin glargine in combination with 5 to 20 micrograms of lixisenatide. The 30-60 SoloSTAR pre-filled pen will deliver 30 to 60 dose steps of

insulin glargine in combination with 10 to 20 micrograms of lixisenatide.

GENMAB ANNOUNCES PHASE III STUDY OF DARATUMUMAB IN COMBINATION WITH CARFILZOMIB IN MULTIPLE MYELOMA Genmab A/S (Nasdaq Copenhagen: GEN) has announced that daratumumab (DARZALEX®) will be investigated in a Phase III clinical study in combination with carfilzomib (KYPROLIS®) and dexamethasone in patients with relapsed/ refractory multiple myeloma. The study will be conducted under a master clinical trial collaboration and supply agreement between Genmab’s licensing partner for daratumumab, Janssen Biotech, Inc., and Onyx Pharmaceuticals, Inc., a wholly-owned subsidiary of Amgen, Inc. The agreement covers all potential opportunities for combining daratumumab and carfilzomib (a proteasome inhibitor) for the treatment of patients with cancer. The first study under this collaboration agreement will be a 450 patient Phase III, randomized, open-label, registration study that will seek to determine if daratumumab in combination with carfilzomib (56 mg/m2 twice weekly) and dexamethasone improves progression-free survival (PFS), compared to carfilzomib and dexamethasone alone in patients with multiple myeloma who have received one to three prior therapies. The study is anticipated to start dosing patients in 2017 and will be sponsored by Amgen.

EUROPEAN COMMISSION APPROVES STELARA Janssen-Cilag International NV (“Janssen”) have announced that the European Commission (EC) has approved the use of STELARA® (ustekinumab) for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNFα) antagonist or have medical contraindications to such therapies. The recommended dosing regimen for STELARA is an initial induction dose (~6 mg/kg) given via a single intravenous (IV) infusion. The first subcutaneous (SC) administration of 90 mg STELARA should take place at week 8 after the intravenous dose. After this, dosing every 12 weeks is recommended. Patients who have not shown adequate response at week 8 after the first SC dose may receive a second SC dose at this time. Patients who lose response on dosing every 12 weeks may benefit from an increase in dosing frequency to every 8 weeks. Patients may subsequently be dosed every 8 weeks or every 12 weeks according to clinical judgement. The EC approval is based on data from three pivotal Phase 3 trials which included approximately 1,400 patients with moderately to severely active Crohn’s disease. The Phase 3 studies showed that treatment with STELARA induced clinical response and maintained clinical remission in a significantly greater proportion of adult patients with moderately to severely active Crohn’s disease after one year of therapy compared to placebo.

“The new Phase III study combining daratumumab with carfilzomib and dexamethasone is an exciting addition to the broad and expansive development program for daratumumab and illustrates the strategy to explore as many clinical development opportunities for daratumumab as possible, and potentially establish daratumumab as the backbone treatment in multiple myeloma,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

STELARA was generally well tolerated as an induction and maintenance therapy in all three studies, and the safety profile of STELARA in the Crohn’s disease clinical development programme remained consistent with five years of cumulative data acquired in patients with psoriasis (with STELARA subcutaneous injections up to 90 mg) and two years of safety data in patients with psoriatic arthritis who were treated with STELARA.

As part of an earlier collaboration agreement between Janssen and Amgen, a separate, ongoing Phase I study (MMY1001 EQUULEUS) is evaluating the safety and pharmacokinetics of daratumumab in combination with a number of backbone multiple myeloma therapies including carfilzomib in newly diagnosed and relapsed/refractory patients with multiple myeloma.

In the placebo-controlled IMUNITI maintenance study adverse events were reported in similar proportions across STELARA and placebo treatment groups, the majority of which were related to gastrointestinal disorders, such as abdominal pain and diarrhoea, and infections/infestations, of which, nasopharyngitis and upper respiratory infection were the most common.

HPN • Professional Top100 - 2016


For Pulmonary Arterial Hypertension For Chronic thromboembolic Pulmonary Hypertension For patients like yours Adempas® is the first and only therapy that stimulates soluble guanylate cyclase (sGC) independently of nitric oxide1 Adempas® is the first treatment to demonstrate significant and sustained clinical efficacy alone or in combination with an ERA or non-IV PCA in PAH patients across multiple endpoints2 Adempas® is the first and only pharmacologic treatment to significantly improve exercise capacity and haemodynamic parameters in patients with CTEPH3 Riociguat significantly improved 6MWD and WHO FC in two independent, randomised, double-blind, placebo controlled trials (PATENT-1, CHEST-1).2,3

Adempas®t (Riociguat) This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SPC for how to report adverse reactions.

ABRIDGED PRODUCT INFORMATION

Refer to Summary of Product Characteristics before prescribing. Presentation: Film-coated tablet containing 0.5mg, 1mg, 1.5mg, 2mg and 2.5mg riociguat. Indications: Chronic thromboembolic pulmonary hypertension (CTEPH): treatment of adult patients with WHO functional class II to III with inoperable CTEPH, persistent or recurrent CTEPH after surgical treatment to improve exercise capacity. Pulmonary arterial hypertension (PAH): In monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (PAH) with WHO functional class II to III to improve exercise capacity. Efficacy has been shown in a PAH population including aetiologies of idiopathic or heritable PAH or PAH associated with connective tissue disease. Dosage and Administration: Adults: Treatment should only be initiated and monitored by a physician experienced in the treatment of CTEPH or PAH. Recommended starting dose: 1mg taken orally, approximately 6-8 hours apart, three times daily for 2 weeks. Increase dose by 0.5mg three times daily every 2 weeks, to maximum of 2.5mg three times daily if systolic blood pressure ≥ 95mmHg. 1.5mg is adequate for some PAH patients. If systolic blood pressure falls below 95mmHg, the dose should be maintained provided the patient does not show any signs or symptoms of hypotension. If at any time during the up-titration phase systolic blood pressure decreases below 95mmHg and the patient shows signs and symptoms of hypotension the current dose should be decreased by 0.5mg three times daily. Individual dose titration at treatment initiation allows adjustment of the dose to the patients needs. The established individual dose should be maintained unless signs and symptoms of hypotension occur. Tablets can generally be taken with or without food. Paediatric: Use of riocguat in children and adolescents should be avoided. Elderly: Exercise particular care during dose titration. Renal Impairment: Severe- Not recommended, Moderate- Exercise particular care during individual dose titration due to risk of hypotension. Hepatic Impairment: Severe-contraindicated, Moderate- Exercise particular care during

individual dose titration due to risk of hypotension. Smokers: Smokers are advised to stop smoking as concentrations of riociguat in smokers are reduced compared to non-smokers. A max dose of 2.5mg three times daily may be required in patients who are smoking or start smoking during treatment. Contraindications: Co-administration with PDE 5 inhibitors (such as sildenafil, tadalfil, vardenafil); severe hepatic impairment (Child Pugh C); hypersensitivity to the active substance or to any of the excipients; pregnancy; co-administration with nitrates or nitric oxide donors (such as amyl nitrite) in any form including recreational drugs called “poppers”; patients with systolic blood pressure below 95 mm Hg at treatment initiation; patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP). Precautions and Warnings: In PAH, studies with Adempas have been mainly performed in forms related to idiopathic or heritable PAH and PAH associated with connective tissue disease. The use of Adempas in other forms of PAH not studied is not recommended. In CEPTH, pulmonary endarterectomy is the treatment of choice as it is potentially curative. Therefore, an expert assessment of operability should be done prior to treatment with Ademapas. Pulmonary veno-occlusive disease (PVOD): Administration of Adempas to PVOD patients is not recommended. Respiratory tract bleeding: Careful monitoring of patients taking anticoagulants is recommended. The risk of serious and fatal respiratory tract bleeding may be further increased under treatment with Adempas, the use should be avoided in patients with a history of serious haemoptysis or who have previously undergone bronchial arterial embolization. Hypotension: Adempas has vasodilatory properties which may result in lowering of the blood pressure. Adempas must not be used in patients with a systolic blood pressure below 95 mmHg. Patients older than 65 years are at increased risk of hypotension. Therefore, caution should be exercised when administering Adempas in these patients. Renal impairment: Data in patients with severe renal impairment (creatinine clearance <30ml/min) are limited and there are no data for patients on dialysis, therefore Adempas is not recommended in these patients. There is increased Adempas exposure in patients with mild and moderate renal impairment. There is a higher risk of hypotension in these patients, particular care should be exercised during individual dose titration. Hepatic impairment: There is no experience in patients with severe hepatic impairment (Child Pugh C); Adempas is contraindicated in these patients. PK data show that higher Adempas exposure was observed in patients with moderate hepatic impairment (Child Pugh B). Particular care should be exercised during individual dose titration.

References: 1. Grimminger F. et al. Eur Respir J 2009; 33: 785-92. 2. Ghofrani H-A et al. New Engl J Med 2013; 369: 330-40 (PATENT-1) and Supplementary Appendix. 3. Ghofrani H-A et al. New Engl J Med 2013; 369: 319-29 (CHEST-1) and Supplementary Appendix. WHO FC = World Health Organization functional class. sGC = soluble guanylate cyclase. 6MWD = 6 minute walking distance

There is no clinical experience with Adempas in patients with elevated liver aminotransferases (>3 x Upper Limit of Normal (ULN)) or with elevated direct bilirubin (>2 x ULN) prior to initiation of treatment; Adempas is not recommended in these patients. Smokers: Plasma concentrations of Adempas in smokers are reduced compared to non-smokers. Dose adjustment may be necessary in patients who start or stop smoking during treatment with Adempas. Paediatric Population: The safety and efficacy in children and adolescents below 18 years have not been established. The use in children and in growing adolescents should be avoided. Adempas contains lactose. Interactions: The concomitant use of Adempas with strong multi pathway cytochrome P450 (CYP) and P-glycoprotein (P-gp) / breast cancer resistance protein (BCRP)inhibitors such as azole antimycotics (e.g. ketoconazole, itraconazole) or HIV protease inhibitors (e.g. ritonavir) is not recommended, due to the pronounced increase in Adempas exposure. The concomitant use of Adempas with strong CYP1A1 inhibitors, such as the tyrosine kinase inhibitor erlotinib and the immuno-suppressive agent cyclosporine A, may increase Adempas exposure. Blood pressure should be monitored and dose reduction of Adempas be considered. Pregnancy and Lactation: Contraindicated during pregnancy and breast-feeding. Side Effects: Very common: headache, dizziness, dyspepsia, peripheral oedema, nausea, diarrhea and vomiting. Common: Gastroenteritis, anaemia, palpitation, hypotension, haemoptysis, epistaxis, nasal congestion, gastritis, gastro-oesophagus reflux disease, dysphagia, gastrointestinal and abdominal pain, constipation, abdominal distension. Uncommon: Pulmonary haemorrhage (fatal pulmonary haemorrhage was reported in uncontrolled long term extension studies. Package Quantities: 42 or 84 film-coated tablets. Legal Category: POM. Marketing Authorisation numbers: EU/1/13/907/001,004,007,010,011,014. Marketing Authorisation Holder: Bayer Pharma AG, 13342 Berlin, Germany. Date of revision: July 2016. © Merck Sharp & Dohme Ireland (Human Health) Limited 2016. All rights reserved. Further information is available on request from: MSD, Red Oak North, South County Business Park, Leopardstown, Dublin 18 or from www.medicines.ie. Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie. Adverse events should also be reported to MSD (Tel: 01-2998700)

Date of preparation: August 2016 CARD-1180850-0001

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